OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique.
This recall has been terminated (originally issued January 11, 2010).
- Recall Initiated
- August 31, 2009
- Posted
- January 11, 2010
- Terminated
- July 17, 2013
- Recall Number
- Z-0507-2010
- Quantity
- 2,876
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
Distribution
Worldwide Distribution.
Lot / Code Info
Catalog Number/Lot Code: LSP46.
Root Cause
Error in labeling
Action Taken
"Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
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