| | Class 2 Recall
AXSOS PLUS LOCKING PLATE SYSTEM |  |
| Date Posted |
April 13, 2009 |
| Recall Number |
Z-1063-2009 |
| Product |
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. |
| Code Information |
All lot codes.
|
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430 |
| For Additional Information Contact |
Karen Ariemma, RAC
201-831-5000
|
Reason for
Recall |
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.
|
| 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 representative.
Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000. |
| Quantity in Commerce |
415 units |
| Distribution |
Nationwide Distribution. |
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