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 Recall Z-0119-2011 · Posted 2010-10-21
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-01-26
Date Terminated2010-10-23
Product Quantity61 untis
Reason for Recall
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.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution -- US, Canada, Singapore Australia, and India.
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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