Stryker’s Craniomaxillofacial announced today that the US Food and Drug Administration (FDA) concluded on Dec. 18, 2008 that its recall of the following Stryker CMF’s Custom Cranial Implant Kits is a Class I recall, which means the product could pose an imminent hazard to health: Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile.

The notification relates to a nationwide voluntary recall initiated by Stryker CMF on Oct. 24, 2008 of 322 Custom Cranial Implant Kits after determining that the sterilization validation of the product was not performed according to appropriate standards.


[Source: FDA/MedScape]