FDA Medical Device Recalls (openFDA)
Stryker Spine: Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spinal implant component
- Recall number
- Z-0429-2010
- Recalling firm
- Stryker Spine
- Product
- Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spinal implant component
- Status
- Terminated
- Initiated
- 2009-10-02
- Posted
- 2009-11-24
- Terminated
- 2013-01-23
- Reason
- Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.
- Root cause
- Device Design
- Action
- Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
- Quantity
- 202
- Distribution
- Nationwide
- Lot, serial or model codes
- Catalog number 48036040, all lot numbers
- 510(k) numbers
- ["K073437"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3004024955
- Firm city
- Allendale
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28