Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080
FDA device recall Z-0401-05 · posted 2005-01-15 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The label on the outside of the shipping box has an incorrect description of the screw diameter.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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.
- Date initiated
- 2004-12-27
- Date posted
- 2005-01-15
- Date terminated
- 2005-03-18
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM (K993166) | Stryker Endoscopy | 2000-08-04 |