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U.S. Department of Health and Human Services

Medical Devices

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Stryker Leibinger USA., Stryker Custom Cranial Implant Kits

Class 1 Recall
Date Recall
Initiated:
October 24, 2008
Product:

Stryker Custom Cranial Implant Kits,
Small (Catalog no. 54-00101), Medium (Catalog no. 54-00102), Large (Catalog no. 54-00103), and Extra large (Catalog no. 54-00104) sizes

This product was distributed from November 5, 2007 through October 23, 2008.

Use:
Custom cranial implant is designed individually for each patient to correct trauma and/or defects in the lower jaw (mandibular), upper jaw and face (maxillofacial) or the cranium and the face (craniofacial bone).
Recalling Firm:
Stryker Leibinger USA
750 Trade Center Way, Suite 200
Portage, Michigan 49002-0482
Reason for Recall:
The company is recalling these products because sterility cannot be assured.
Public Contact:
The company may be contacted at 1-269-324-5346, ext. 4258.
FDA District:
Detroit
FDA Comment:

The company’s sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem by a recall letter dated October 24, 2008.

The letter advised them of the risk for serious infections, and was 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.

For more information about this recall, please see the company’s press release

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.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program.  See the nearby link to MedWatch.