Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
This recall has been terminated (originally issued December 18, 2008).
- Recall Initiated
- October 24, 2008
- Posted
- December 18, 2008
- Terminated
- December 31, 2009
- Recall Number
- Z-0509-2009
- Quantity
- 322 of all products.
- Firm Location
- Portage
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility.
Distribution
Nationwide Distribution.
Lot / Code Info
All units.
Root Cause
Process control
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.
More recalls by Stryker Craniomaxillofacial Division
Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, M...
Dec 18, 2008