Z-2546-2014 Class II Terminated
FDA device recall Z-2546-2014 was initiated by Zimmer, Inc. on Jul 22, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Sep 15, 2015). Affected quantity: 972,125 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 3, 2014
- Initiation Date
- Jul 22, 2014
- Termination Date
- Sep 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 972,125 units
Product Description
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution.
Code Information
Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2546-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026