Zimmer, Inc.: Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM

Is my product affected?

Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM

• UPC 00579104100
• UPC 00579104200
• UPC 00598304048
• UPC 00598304148

Check against the official notice below — it lists the full affected range.

What happened

Zimmer, Inc. is recalling approximately 972,125 sterile-packaged knee instrument fixation screws distributed worldwide. The screws come in six different package configurations, and the recall was initiated because multiple test samples from each configuration failed simulated distribution and shipping tests. During testing, the devices either breached the inner or outer package trays or lost seal integrity, which could compromise sterility.

The affected products include 48MM headed screws, 48MM headless screws, MIS headed screws, and MIS headless screws with item numbers 00579104100, 00579104200, 00598304048, and 00598304148, with expiration dates prior to November 2023. The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: Worldwide Distribution. Quantity: 972,125 units Lot/code info: Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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