Zimmer Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lot Number: 60998487.
Products Sold
Lot Number: 60998487.
Zimmer Inc. is recalling Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporou due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MN, MS, NY, OH, TN, TX, WI
Page updated: Jan 10, 2026