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U.S. Department of Health and Human Services

Class 2 Device Recall Knee Instrument Fixation Screws

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 Class 2 Device Recall Knee Instrument Fixation Screwssee related information
Date Initiated by FirmJuly 22, 2014
Date PostedAugust 26, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall NumberZ-2546-2014
Recall Event ID 68818
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductKnee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Code Information Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer 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.
FDA Determined
Cause 2		Package design/selection
ActionZimmer 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.
Quantity in Commerce972,125 units
DistributionWorldwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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