Recall Z-0512-2009 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Stryker Craniomaxillofacial Division
Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
| Date | Dec 18, 2008 (initiated Oct 24, 2008) |
| Status | Terminated |
| Reason | Lack of assurance of sterility. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 322 of all products. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT Stryker Leibinger, Apr 15, 2005 |