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Terminated

Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.

FDA Recall Z-1443-2010 · Posted 2010-04-27

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWB
Date Initiated2010-03-02
Date Terminated2012-08-06
Product Quantity790 unit

Reason for Recall

Literature did not include the design change to a smaller cannulation diameter.

Firm Action

An Urgent Correction - Operative Technique letter was sent to direct accounts, Hospital Risk Management, Chief of Orthopaedics and Surgeons that use the Gamma3 system. Notification letters were sent via Federal Express on March 2, 2010. The letter identified the product and described the issue. It also discussed the potential hazards and risk mitigation. Customers are to contact Customer Service at 1-866-OR-ASSIST or any of the other firm representatives listed in the letter.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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