Recall Z-2099-2013 ยท HWC Screw, Fixation, Bone
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.
| Date | Aug 27, 2013 (initiated Jul 8, 2013) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000080 | ASNIS III CANNULATED SCREW SYSTEM Howmedica Osteonics Corp., Apr 3, 2000 |