Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Published September 3, 2014 · Recall initiated: July 22, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution.
- Lot
- Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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