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Terminated

Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136

FDA Recall Z-1158-06 · Posted 2006-06-17

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeHSX
Date Initiated2006-04-12
Date Terminated2007-04-11
Product Quantity4 units

Reason for Recall

Mispackaging-A size 5 femoral component, right, box had a size 5 left component in the box.

Firm Action

All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006.

Root Cause

Other

Distribution Pattern

Worldwide-including states of LA, NC, IN, and countries of France, and Turkey

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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