Stryker Craniomaxillofacial Division 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Stryker Craniomaxillofacial Division
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Stryker Craniomaxillofacial Division is recalling Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, M due to Lack of assurance of sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026