Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Tr
FDA device recall Z-2340-2010 · posted 2010-09-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The nail has no thread for the set screw hindering insertion.
- Action taken
- Urgent Product Recall letters were sent on July 23, 2010 by Federal Express to Stryker branches. A corrected letter was sent on July 26, 2010 to correct an error in the size of the screw. Additionally, letters were sent on July 26, 2010 to Hospital Risk Managers, Chief of Orthopaedics and Surgeons. The letter identified the affected product, explained the issue, discussed the potential hazard, and the risk mitigation. Customers are to examine their inventory, retrieve all affected product and return it; then reconcile all products on the Product Recall Acknowledgement Form and fax it back. Questions should be directed towards Richard Wolyn at 201-972-2100.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 12 units
- Distribution
- Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.
- Date initiated
- 2010-07-23
- Date posted
- 2010-09-02
- Date terminated
- 2012-08-06
- 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 |
|---|---|---|
| GAMMA3 NAIL SYSTEM (K034002) | Howmedica Osteonics Corp. | 2004-01-15 |