Recall Issued for Stryker Custom Cranial Implant Kits

Laurie Barclay, MD

Disclosures

December 24, 2008

December 24, 2008 — The US Food and Drug Administration (FDA) has issued a class 1 recall for Stryker Custom Cranial Implant Kits, manufactured by Stryker Leibinger USA, because of lack of assurance of sterility and risk for infection, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. Class 1 recalls warn of situations in which there is a reasonable probability that use of the recalled products will cause serious injury or death.

The recall affects all sizes of the cranial implant kit distributed from November 5, 2007, through October 23, 2008. These custom implants are individually designed to correct patient-specific trauma-related and/or other defects of the lower jaw (mandibular), upper jaw, and face (maxillofacial), or the cranium and the face (craniofacial bone).

A letter dated October 24, 2008, notified sales representatives, risk managers, implanting surgeons, and other appropriate healthcare professionals of the recall, stating that sterility could not be assured and that there was a risk for serious infections. In addition, clinicians were advised to follow up with patients for infections for at least 6 months after surgery, and instructions were provided for identifying and returning any remaining implant kits.

Adverse events related to use of Stryker Custom Cranial Implant Kits should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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