Z-0401-05

Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078...

Name: Z-0401-05 Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078...
Creator: Stryker Endoscopy
Published: 2004-12-27
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2004-12-27 / Terminated / root cause: labeling and UDI

FDA source

Stryker Endoscopy began a recall of Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080 on 2004-12-27. The reason FDA records is "The label on the outside of the shipping box has an incorrect description of the screw diameter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0401-05
Status: Terminated
Initiated: 2004-12-27
Posted: 2005-01-15
Terminated: 2005-03-18
Recalling firm: Stryker Corp.
Product: Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080
Product code: HWC Screw, Fixation, Bone
Reason for recall: The label on the outside of the shipping box has an incorrect description of the screw diameter.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Part Number: 234-010-078, Lot # 32101; Part Number: 234-010-080, Lot # 32103

Product code HWC

K993166Class IIStryker Bioabsorbable Interference Screw SystemStryker Endoscopy / cleared 2000-08-04

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)