FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080
- Recall number
- Z-0401-05
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080
- Status
- Terminated
- Initiated
- 2004-12-27
- Posted
- 2005-01-15
- Terminated
- 2005-03-18
- Reason
- The label on the outside of the shipping box has an incorrect description of the screw diameter.
- Root cause
- Other
- Action
- Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.
- Quantity
- 16 units of 078, 284 units of 080
- Distribution
- 6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.
- Lot, serial or model codes
- Part Number: 234-010-078, Lot # 32101; Part Number: 234-010-080, Lot # 32103
- 510(k) numbers
- ["K993166"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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