—#94311

Product

NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K933785
Affected lot / code info: Lot Number: 61246477.

Why it was recalled

Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.

Root cause (FDA determination)

Employee error

Action the firm took

The firm sent an URGENT MARKET WITHDRAWAL to its sales force and distributors on 1/26/2010. The letter identifies the affected product and explains the reason for the Market Withdrawal. The letter also explains the clinical implications and instructs consignees to locate any unused devices and quarantine them immediately. A physical count should be carried out of all affected devices and recorded on the Inventory Return Certification Form that's included with the letter. A copy of the letter should be faxed to Zimmer, Inc. and the affected product should be returned along with the form to the firm.

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution -- US, Canada, Singapore Australia, and India.

Timeline

Recall initiated: 2010-01-26
Posted by FDA: 2010-10-21
Terminated: 2010-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.