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.”