Recall Z-0844-2010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S; Sterile, TI Alloy; Stryker Trauma GmbH, Germany; Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
| Date | Feb 24, 2010 (initiated Dec 29, 2009) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Root cause | Packaging |
| Action | 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 t |
| Quantity | 702 total, all sizes |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051590 | T2 ANKLE ARTHRODESIS NAIL Howmedica Osteonics Corp., Jul 29, 2005 |