FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
- Recall number
- Z-2099-2013
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
- Status
- Terminated
- Initiated
- 2013-07-08
- Posted
- 2013-08-27
- Terminated
- 2015-03-31
- Reason
- Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
- Root cause
- Process control
- Action
- Stryker sent an Urgent Medical Device Removal letter dated July 8, 2013 via Fed Ex to all affected customers. The letter identified the affected product, product issues, potential hazards, risk mitigation and actions to be taken. Customers were instructed to return all affected products available to Stryer Osteosynthesis or contact Stryer customer service and complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-251-3635. Questions can be directed to Stryker at 201-972-2100.
- Quantity
- 23 units
- Distribution
- USA Nationwide Distribution in the states of: FL. OH, TX, & VA
- Lot, serial or model codes
- Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit
- 510(k) numbers
- ["K000080"]
- PMA numbers
- not on file
- Product code
- HWC
- 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
- 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