Recalls / —
—#85400
Product
OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols instruct surgeons on proper surgical technique.
- FDA product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K022555
- Affected lot / code info
- Catalog Number/Lot Code: LSP48.
Why it was recalled
Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
Root cause (FDA determination)
Error in labeling
Action the firm took
"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).
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Drive, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2009-08-31
- Posted by FDA
- 2010-01-11
- Terminated
- 2013-07-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #85400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.