By device type

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: device recalls

FDA device recalls whose record carries FDA's device name “Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented”: 299 records; the 81 recalls led by one, newest first.

More about these records

The name is FDA's classification, as written in the record.

Recent recalls

1 of 81

Oct. 14, 2026Class IIFDA · Medical device

Onkos Surgical Inc. My3D Personalized Pelvic Implant… and 1 more product

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Filed by: Onkos Surgical, Inc. · Also listed under Onkos Surgical

More recalls

80 in all years

Nov. 12, 2025Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene… and 1 more productClass IIZimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is… Recall began Sept. 26, 2025
Oct. 22, 2025BioPro Femoral Head (Metal 22… and 5 more productsClass IIPotential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk… Recall began Sept. 9, 2025
July 30, 2025Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular… and 1 more productClass IIDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. Recall began June 12, 2025
April 23, 2025restor3d Cordera Hip System…Class IIThe hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to…
Nov. 27, 2024NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System…Class IIMislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted Recall began Sept. 19, 2024
May 1, 2024TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision… and 11 more productsClass IIThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Recall began Feb. 27, 2024
Oct. 4, 2023MobileLink Acetabular Cup System…Class IIProduct is labeled with incorrect offset. Recall began July 14, 2023
April 5, 2023CoCr Femoral Head…Class IIUpdate the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the… Recall began Feb. 27, 2023
March 29, 2023G7 Acetabular System…Class IIThe outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. Recall began Feb. 6, 2023
Nov. 2, 2022EMPOWR Acetabular System… and 1 more productClass IIHip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available… Recall began Aug. 12, 2022
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Feb. 23, 202232MM -4 V40 TAPER VIT HEAD… and 1 more productClass IIThere is a potential for the outer Tyvek lid to de-bond from the sealed package. Recall began Dec. 21, 2021
Nov. 24, 2021OMNI K2 Hip Stem…Class IIThe device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event… Recall began Oct. 1, 2021
Oct. 27, 2021REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self… and 1 more productClass IIThere is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
July 28, 2021Exactech Connexion GXL acetabular polyethylene liners used in the… and 21 more productsClass IIRisk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical…
Dec. 2, 2020iTotal Hip Replacement System…Class IIIncorrect hip components were provided in kits. Recall began Sept. 21, 2020
Oct. 28, 2020EMPOWR Acetabular System *** EMPOWR Acetabular Cup…Class IIDue to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to… Recall began Sept. 9, 2020
Oct. 14, 2020Dual Mobility Vivacit-E Bearing…Class IIThe outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. Recall began Aug. 14, 2020
May 27, 2020Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell… and 15 more productsClass IIThe Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package… Recall began April 16, 2020
May 20, 2020EMPOWR Acetabular System…Class IIThe firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate… Recall began Oct. 22, 2019
April 22, 2020djosurgical Linear Neck Trials with Spring Sides…Class IIThe retaining ring on the neck trials has a potential to fail interoperatively. Recall began July 10, 2018
Dec. 4, 2019Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF…Class IIBoxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) Recall began Oct. 3, 2019
Oct. 30, 2019OMNI Hip System Model…Class IIStems missing porous coating on the device. Recall began Sept. 11, 2019
Oct. 16, 2019iTotal Hip Replacement System… and 1 more productClass IITwo femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Recall began Aug. 22, 2019
June 19, 2019Conformis iTotal Hip Replacement System: HBS-033-00xx-010101… and 1 more productClass IIDiscrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in… Recall began March 29, 2019
March 27, 2019smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14… and 1 more productClass IIComplaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within… Recall began Feb. 19, 2019
Jan. 23, 2019iTotal Hip Replacement System…Class IIThe stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The… Recall began Oct. 16, 2018
Aug. 1, 2018OMNI Hip System…Class IIThe Internal packaging, the pouch and patient labels are improperly labeled. Recall began May 18, 2018
July 11, 2018Zimmer M/L Taper Hip Prosthesis Plasma Sprayed… and 14 more productsClass IIM/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the… Recall began May 30, 2018
April 4, 2018Zimmer M/L Taper Hip Prosthesis… and 1 more productClass IICertain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper… Recall began March 1, 2018
March 21, 2018Accolade and Restoration hip product… and 1 more productClass IIInner and outer sterile barriers not fully sealed. Recall began July 21, 2017
March 21, 2018Trabecular Metal Primary Hip Prosthesis…Class IITwo lots of hip implants are mislabeled. Recall began Jan. 3, 2018
Jan. 10, 2018PPS RingLoc+ Acetabular Shell…Class IIDevice was distributed with the etching missing from the product. Recall began June 29, 2017
March 22, 2017Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644…Class IILot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
Jan. 25, 2017RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High… and 1 more productClass IIProduct complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in… Recall began Dec. 19, 2016
Aug. 3, 2016Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip…Class IIImpactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. Recall began June 3, 2016
July 27, 2016MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636Class IIReported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck. Recall began June 21, 2016
March 16, 2016M/L Taper Hip Prosthesis (Item: 00-7711-012-20…Class IIZimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5… Recall began Feb. 11, 2016
Nov. 18, 2015Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads…Class IIComplaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. Recall began Sept. 8, 2015
Sept. 30, 2015Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant componentClass IIit was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a… Recall began June 25, 2015
Sept. 9, 2015Vision RingLoc Shell 50 mm Size 23…Class IIThe device was assembled without screw hole plugs. Recall began July 28, 2015
Sept. 2, 2015APEX INTERFACE Hemi 54X and Flared 56X…Class IIThe device may have improper screw hole placement due to inaccurate location of the index line. Recall began June 4, 2015
June 17, 2015Mallory/Head Primary Hip System… and 3 more productsClass IIIBiomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number)… Recall began April 16, 2015
May 27, 2015Stryker Howmedica Osteonics RESTORATION Acetabular Augment System… and 2 more productsClass IIThe peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term… Recall began Aug. 15, 2014
March 4, 2015CoCr Femoral Head… and 4 more productsClass IIPotential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the… Recall began Dec. 17, 2014
Feb. 25, 2015Mallory Head 4 Finned Acetabular Shell 50 mm… and 1 more productClass IIBiomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840)… Recall began Jan. 9, 2015
Dec. 31, 2014Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either…Class IIZimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor…
Dec. 24, 2014Bone Screw…Class IIAnalysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific… Recall began Nov. 21, 2014
Oct. 29, 2014Microseal Augmented (20 degrees) Liner…Class IIIncorrect dimension on four liners was detected Recall began Sept. 23, 2014
July 16, 2014Zimmer M/L Taper Hip Stem Standard & Extended Offset… and 2 more productsClass IIBlack residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Recall began May 23, 2014
July 2, 2014VerSys Hip System…Class IIDuring routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem… Recall began May 19, 2014
April 30, 2014TRABECULAR METAL MODULAR ACETABULAR SYSTEM…Class IIThe shell was missing the locking ring.
March 12, 2014FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems…Class IIPackaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's… Recall began Feb. 7, 2014
Feb. 12, 2014***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm…Class IIExactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. Recall began Sept. 11, 2013
Jan. 1, 2014REFLECTION(R)…Class IIOne batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell. Recall began Nov. 25, 2013
June 12, 2013Active Articulation E1…Class IIBiomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that… Recall began April 26, 2013
May 29, 2013Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner…Class IIDePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box.… Recall began March 7, 2012
Feb. 13, 2013Trilogy F/M Acetabular Shell without holes… and 7 more productsClass IISome units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30%… Recall began Sept. 14, 2012
Dec. 26, 2012SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly… and 19 more productsClass IIAn Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement…
Dec. 26, 2012Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector…Class IIDePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The…
Nov. 28, 2012The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D…Class IIZimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint… Recall began Sept. 20, 2012
Nov. 7, 2012Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28… and 2 more productsClass IIThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. Recall began Sept. 5, 2012
Aug. 29, 2012Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during…Class IIIn the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted… Recall began July 24, 2012
Dec. 1, 2011Zimmer ZMR Hip System Instructions for Use… and 3 more productsThis recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. Recall began Oct. 21, 2011
Nov. 16, 2011Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary… and 2 more productsLack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain…
Oct. 14, 2010Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes…The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter. Recall began Aug. 18, 2010
Aug. 26, 2010VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA… and 1 more productZimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In… Recall began July 5, 2010
Aug. 12, 2010Trabecular Metal acetabular revision system buttress augment size… and 3 more productsThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches. Recall began April 6, 2010
May 26, 2010Mallory Head Calcar Provisional… and 14 more productsThe firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. Recall began March 10, 2010
March 2, 2010Trident Acetabular Hip System Polyethylene Inserts… and 2 more productsStryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio… Recall began Feb. 17, 2006
Nov. 13, 2009Zimmer VerSys Hip System Femoral Head…Manufacturing material may be present on the surface of the implant. Recall began Aug. 3, 2009
April 21, 2009Reflection…Liners measuring 28 mm ID and were mismarked as 32 mm. Recall began Nov. 21, 2008
March 19, 2008Zimmer Trilogy Acetabular System Shell with Cluster Holes…Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim. Recall began Oct. 19, 2007
March 12, 2008Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5…Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as… Recall began Nov. 1, 2007
Dec. 14, 2007Hipstar TMZF Cementless Hip Stem Protocol…Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of… Recall began Sept. 28, 2007
Dec. 14, 2007Hipstar V40 Femoral Stem-127 degrees… and 11 more productsMis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes. Recall began Sept. 28, 2007
Oct. 27, 2007Biomet Orthopedics Apical Hole Plug…Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended. Recall began Aug. 9, 2007
June 9, 2007AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment…The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the… Recall began July 21, 2006
April 27, 2006Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm…Voids in the porous coating of a component used in total hip replacement surgery. Recall began Jan. 12, 2006
March 7, 2006Zimmer Natural Hip System Collarless Stem…Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.
Jan. 28, 2003Versys Hip System femoral stem… and 5 more productsThe femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.

Reports to FDA about this kind of device

From Nov. 11, 2021 to Oct. 20, 2026, FDA's adverse event database (MAUDE) received 27,224 reports for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (FDA product code LPH): 38 reporting a death; 24,602 an injury; 2,581 a malfunction.

Problems named most in the reports:

Adverse Event Without Identified Device or Use Problem 12,513Device Dislodged or Dislocated 5,551Naturally Worn 1,545Fracture 1,331Osseointegration Problem 1,043Material Erosion 873

Reports come from manufacturers, hospitals, doctors and patients. FDA does not confirm that a device caused an event, a malfunction report may involve no harm, and a count follows how many devices are in use. Counts as returned by openFDA's device adverse event service; in FDA's words, do not rely on openFDA to make decisions regarding medical care. Talk to your doctor about a device you use.

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