Recall Z-1063-2009 ยท HRS Plate, Fixation, Bone
Stryker Howmedica Osteonics Corp.
AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws.
| Date | Apr 13, 2009 (initiated Nov 24, 2008) |
| Status | Terminated |
| Reason | Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break. |
| Root cause | Other |
| Action | "Urgent Product Recall" letters were sent to Stryker Orthopaedics Branches/Agencies, Chief of Orthopaedics, Hospital Risk Management and Surgeons on November 24, 2008 via Federal Express. The letters described the issue and provided the following instructions: 1. Examine your inventory and determine if you have any of the affected product, 2. Remove and quarantine affected product from your inventory, 3. Complete the attached Product Recall Acknowledgement Form (and fax to Stryker Orthopaedics at 201-831-6069), and 4. Return the affected product to your Stryker Orthopaedics Sales representati |
| Quantity | 415 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061012 | AXSOS PLUS LOCKING PLATE SYSTEM Howmedica Osteonics Corp., May 19, 2006 |