Recall Z-0401-05 ยท HWC Screw, Fixation, Bone
Stryker Endoscopy
Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080
| Date | Jan 15, 2005 (initiated Dec 27, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993166 | STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy, Aug 4, 2000 |