—#89794

Product

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 product code: HWB — Extractor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: LIES-OT

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-03-02
Posted by FDA: 2010-04-27
Terminated: 2012-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.