—#81880

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070214
Affected lot / code info: Lot Number: 60998487.

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.

Timeline

Recall initiated: 2009-04-29
Posted by FDA: 2009-06-26
Terminated: 2009-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.