Recall Z-1443-2010 ยท HWB Extractor
Stryker Howmedica Osteonics Corp.
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.
| Date | Apr 27, 2010 (initiated Mar 2, 2010) |
| Status | Terminated |
| Reason | Literature did not include the design change to a smaller cannulation diameter. |
| Root cause | 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 | 790 unit |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.