Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog Number: 18181130S; Sterile, TI Alloy; Stryker Trauma GmbH
FDA device recall Z-0842-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Action taken
- Urgent Product Recall notification letters were sent to branches on 12/29, 2009, with a corrected version that included a list of catalog numbers and code numbers on January 11, 2009. Letters were also sent by Fed Ex on January 11, 2009 to Hospital Risk Management, Chief of Orthopaedics and surgeons who may have used the device. The letters identified the affected product, described the issue, and the hazards involved. The letter also asked customers to examine their inventory and hospital locations to identify the affected product. They are to retrieve all affected product and return it to their branch or agency warehouse for reconciliation. Customers are to reconcile all products utilizing the Product Recall Accountability Form. Questions should be directed to 201-972-2100.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 702 total, all sizes
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-12-29
- Date posted
- 2010-02-24
- Date terminated
- 2012-08-06
- Location
- Mahwah, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T2 ANKLE ARTHRODESIS NAIL (K051590) | Howmedica Osteonics Corp. | 2005-07-29 |