PlainRecordsMedicrea… and 1 more product
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Filed by: Medicrea International
Brand recall history
Medicrea International recalls
Every FDA recall record we found for Medicrea International, newest first. Updated Oct. 11, 2026.
9
9 recalls since 2020. The most recent was on Jan. 21, 2026.
- Last 12 months
- 1
- Most recent
- 2026-01
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2020–202620212223242526
Class I (FDA, most serious)Other recalls
Recent recalls
1 of 9More recalls
8- Feb. 12, 2025UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two… Class IIDue to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i…
- Aug. 30, 2023Impix 3D… and 10 more products Class IIThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Nov. 25, 2020MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior… Class IITightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a…
- March 18, 2020Pedicle Screws… and 1 more product Class IIAn internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after…
- Feb. 26, 2020Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500 Class IIIncompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
- Feb. 19, 2020Medicrea TLIF-B Holder… Class IIInner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
- Jan. 29, 2020Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product… and 1 more product Class IIConical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
- Jan. 8, 2020Medicrea Pass LP… Class IIIt has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm…
No recalls match.
How we match: a recall is listed here when the agency names Medicrea International as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.