Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-001
FDA device recall Z-0511-2009 · posted 2008-12-18 · Terminated
Recall details
- Recalling firm
- Stryker Craniomaxillofacial Division
- Reason for recall
- Lack of assurance of sterility.
- Action taken
- The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KKY
- Quantity affected
- 322 of all products.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-10-24
- Date posted
- 2008-12-18
- Date terminated
- 2009-12-31
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K043250) | Stryker Leibinger | 2005-04-15 |