Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirch
FDA device recall Z-2016-2012 · posted 2012-07-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails.
- Action taken
- Stryker Orthopaedics sent Recall letters/Customer Response forms dated 1/26/2012 and 1/30/2012 on 1/27/2012 and 1/31/2012 via FEDEX to their branches, hospitals and surgeon accounts respectively. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to contact their Stryker representative to arrange for return of any affected product. Customers were asked to fax back the attached Product Recall Acknowledgment Form as soon as possible to 201-831-6069.. For any questions customers should call 201-972-2100. For questions regarding this recall 201-831-5970.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 532 units.
- Distribution
- Nationwide.
- Date initiated
- 2012-01-26
- Date posted
- 2012-07-16
- 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 |
|---|---|---|
| T2 ARTHRODESIS NAIL SYSTEM (K020384) | Howmedica Osteonics Corp. | 2002-05-06 |