OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 0743
FDA device recall Z-0507-2010 · posted 2010-01-11 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- 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).
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 2,876
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-08-31
- Date posted
- 2010-01-11
- Date terminated
- 2013-07-17
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCOLADE C FEMORAL STEMS (K022555) | Howmedica Osteonics Corp. | 2002-08-26 |