FDA Device recall Z-2546-2014
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
- FDA Device
- Class II
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class II recall of Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM by Zimmer, citing zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2546-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-22 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | n/a |
Product
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
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.
Identifiers
| code_info | Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2546-2014%22
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