Device product
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Z-2546-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 972,125 units
- Official record key
device-enforcement:Z-2546-2014
Official wording
Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Code information: Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Device software or design
design verification test failures