Date Initiated by Firm | March 02, 2010 |
Date Posted | April 27, 2010 |
Recall Status1 |
Terminated 3 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 NJ 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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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