Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
FDA Recall Z-0501-2010 · Posted 2009-12-14
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-11-13
Date Terminated2010-10-15
Product Quantity22
Reason for Recall
The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
Firm Action
Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.
Root Cause
Packaging process control
Distribution Pattern
Nationwide, Korea and Switzerland.
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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