Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. These are single use implantable devices sold sterile.
FDA Recall Z-0871-2009 · Posted 2009-01-09
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2008-11-25
Date Terminated2009-11-12
Product Quantity10
Reason for Recall
Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.
Firm Action
Zimmer distributors were notified by email of letter dated 11/25/08 on 11/25/08. This letter is entitled "URGENT: DEVICE RECALL." Secondary consignees/user accounts were notified by a copy of the 11/25/08 letter, which was sent on or before 12/05/08. Consignees were instructed to stop using the product and to return it to Zimmer. For further information, please contact Zimmer, Inc. by telephone by dialing 800-613-6131.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.
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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