Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01. Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.
FDA Recall Z-1477-2009 · Posted 2009-06-26
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-04-29
Date Terminated2009-10-21
Product Quantity14
Reason for Recall
The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.
Firm Action
Zimmer, Inc. issued an "Urgent: Device Recall" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265.
For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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