Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments w
FDA device recall Z-1443-2010 · posted 2010-04-27 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Literature did not include the design change to a smaller cannulation diameter.
- Action taken
- 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
- Status
- Terminated
- Product code
- HWB
- Quantity affected
- 790 unit
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-03-02
- Date posted
- 2010-04-27
- Date terminated
- 2012-08-06
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.