—#128787

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11

Why it was 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.

Root cause (FDA determination)

Package design/selection

Action the firm took

Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2014-07-22
Posted by FDA: 2014-08-26
Terminated: 2015-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128787. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.