PlainRecordsReflection…
- Reason
- Liners measuring 28 mm ID and were mismarked as 32 mm.
- Status
- Terminated
- Distribution
- International Distribution to Canada, France, Germany and Switzerland.
- Date posted by the FDA
- April 21, 2009
- Risk class
- Not given in FDA's device recall database (this entry has no enforcement report in openFDA's files)
- Status
- Terminated (FDA's definition: FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard; as in openFDA's device recall database of Nov. 2, 2026)
- Filed by
- Smith & Nephew Inc
- Product
- Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
- Reason
- Liners measuring 28 mm ID and were mismarked as 32 mm.
- Distribution pattern
- International Distribution to Canada, France, Germany and Switzerland.
- Quantity
- 19 units
- Codes and lots
- Part Number: 71740250, Lot Numbers: 08FM05400 and 08FM05400B.
- Recall started
- Nov. 21, 2008
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Process control
- What the company told customers
- All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.
- Recall number
- Z-1004-2009
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Liners measuring 28 mm ID and were mismarked as 32 mm.”Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures., FDA enforcement report, 2009-04-21. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
This recall among the others
- FDA's enforcement report came 151 days after the firm started the recall. For half of the 781 FDA medical device recall events reported in 2009 with a start date, it took 89 days or fewer (by year).
- Smith & Nephew: 23 other recalls or notices on this site in the three years before this one (from April 22, 2006).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device recall database (CDRH) entry, recall number Z-1004-2009. This entry has no enforcement report in openFDA's files. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1004-2009, April 21, 2009. "Reflection." PlainRecords, https://plainrecords.com/recall/device/z-1004-2009/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections