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Terminated

Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

FDA Recall Z-1141-2010 · Posted 2010-03-16

Recall StatusTerminated
Product CodeJWH
Date Initiated2007-08-20
Date Terminated2010-03-16
Product Quantity4 units

Reason for Recall

A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

Firm Action

Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.

Root Cause

Process design

Distribution Pattern

Product went to 2 US Stryker branches.

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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