AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking… recallZ-1063-2009 · Stryker Howmedica Osteonics Corp. · initiated Nov 24, 2008
Terminated All recalls posted in April 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Other
What the company is doing
"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.
Recall details
- Recall number
- Z-1063-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 24, 2008
- Posted by the FDA
- Apr 13, 2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 415 units
- Product code
- HRS
- FDA submissions
- K061012
- Distribution
- Nationwide Distribution.
Product description
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 (models, lots, serial numbers)
All lot codes.
Other devices under the same FDA submission
3 devices cleared under K061012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AXSOS 437330Stryker GmbH · PLATE, FIXATION, BONE1 report
- AXSOS 437532Stryker GmbH · PLATE, FIXATION, BONE1 report
- AXSOS 437103Stryker GmbH · PLATE, FIXATION, BONE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 50850).
- Z-1062-2009 · TerminatedAxSOS 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 s…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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