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Terminated

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

FDA Recall Z-2546-2014 · Posted 2014-08-26

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-07-22
Date Terminated2015-09-15
Product Quantity972,125 units

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.

Firm Action

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.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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