Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW Recalled by Zimmer, Inc. Due to Zimmer is recalling sterile-packaged implants and instruments packaged...

Date: July 22, 2014
Company: Zimmer, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.

Affected Products

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

Quantity: 972,125 units

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide Distribution.

About Zimmer, Inc.

Zimmer, Inc. has 437 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report