Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm T
FDA device recall Z-2099-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 23 units
- Distribution
- USA Nationwide Distribution in the states of: FL. OH, TX, & VA
- Date initiated
- 2013-07-08
- Date posted
- 2013-08-27
- Date terminated
- 2015-03-31
- Location
- Mahwah, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASNIS III CANNULATED SCREW SYSTEM (K000080) | Howmedica Osteonics Corp. | 2000-04-03 |