Recalls / —
—#77488
Product
AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The screwdrivers of the AxSOS system are multiple use instruments used to insert screws into bones.
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K061012
- Affected lot / code info
- All lot codes.
Why it was recalled
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 (FDA determination)
Other
Action the firm took
"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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2008-11-24
- Posted by FDA
- 2009-04-13
- Terminated
- 2010-04-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #77488. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.