T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical Protocol instruc
FDA device recall Z-1818-2009 · posted 2009-08-18 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).
- Action taken
- Important Product Correction Letters, dated November 17, 2006, were sent to all Stryker Branches/agencies via Federal Express. The letter stated the issue and asked consignees to examine their inventory and contact their sales reps. It also told them to destroy the affected Operative Techniques by cutting them in half and discarding them, complete the attached Acknowledgment Form, and fax a signed copy of that form to 201-831-6069. The letter stated that Stryker Orthopaedics Customer Service reps would place consignees' re-orders for the product being destroyed. Also, the letter stated that in the interim a correct revision of the Operative Technique could be found online. Customers are to contact Dave O'Dell at 201-831-5277 or Rita Intorrella at 201-831-5825 with any questions.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 1270
- Distribution
- Nationwide Distribution
- Date initiated
- 2006-11-17
- Date posted
- 2009-08-18
- Date terminated
- 2009-08-20
- 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 |
|---|---|---|
| T2 ANKLE ARTHRODESIS NAIL (K051590) | Howmedica Osteonics Corp. | 2005-07-29 |