Recall Z-0065-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed lock
| Date | Oct 14, 2014 (initiated Jul 24, 2014) |
| Status | Terminated |
| Reason | Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. |
| Root cause | Mixed-up of materials/components |
| Action | Stryker Orthopaedics sent an "Urgent Medical Device Removal" letter dated July 23, 2014 and Business Reply Form to their Branches/Agencies via e-mail on July 23, 2014 and their Hospital Risk Management was sent Notification Letters and Product Accountability Forms via FedEx (with return receipt) by July 24, 2014. The recall letter informed the customer of the problem. The customer was asked to return all affected products available to Stryker Osteosynthesis, c/o Paul Jahnke, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, REF: PFA #2014-101 or Contact Stryker's customer service a |
| Quantity | 484 units |
| Distribution | US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131365 | T2 TIBIAL NAILING SYSTEM Stryker Trauma AG, Oct 10, 2013 |