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U.S. Department of Health and Human Services

Class 2 Device Recall Implant Extraction Set Implant Extraction Guide Module One & Two

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 Class 2 Recall
Implant Extraction Set Implant Extraction Guide Module One & Two
see related information
Date Posted April 27, 2010
Recall Status1 Terminated on August 06, 2012
Recall Number Z-1443-2010
Recall Event ID 55049
Product Classification Extractor - Product Code HWB
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.
Code Information LIES-OT
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Literature did not include the design change to a smaller cannulation diameter.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
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.
Quantity in Commerce 790 unit
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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