FDA Class 1 Recall: Stryker Cranial Implants

Jessica Smagacz

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Stryker Leibinger USA, a firm based in Portage, Michigan, is recalling it Stryker Custom Cranial Implant kits product. FDA reported this product as recalled on October 24, 2008.

The products use: This product was used to correct trauma and or defects in the lower jaw, upper jaw and face or the cranium and face.

Reason for recall: Stryker is recalling this product because sterility cannot be assured.

Contact information: 269-324-5346, ext. 4258.

The company was notified of the problem before October 24; the letter advised them of the risk of serious infections.

FDA called this a class 1 recall. Class 1 recalls are “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.”

FDA advises consumers and health care professionals to report adverse reactions or quality problems experienced to FDA’s MedWatch Adverse Event Reporting.