FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1063-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Status
- Terminated
- Initiated
- 2008-11-24
- Posted
- 2009-04-13
- Terminated
- 2010-04-06
- 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 representative. Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000.
- Quantity
- 415 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All lot codes.
- 510(k) numbers
- K061012
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06