Stryker Craniomaxillofacial has issued a nationwide recall of its Custom Cranial Implant Kits; Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile
Stryker’s Craniomaxillofacial (CMF) business unit announced today that the U.S. 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. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.
Physicians and hospitals who have product that corresponds to the catalogue numbers listed above should stop implanting the product immediately and return it to Stryker CMF. Stryker recommends that patients who have received these implants be monitored by their physicians for signs of infection for at least six months post-implantation.
Stryker CMF previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits and requested that they return any remaining products to Stryker CMF. Stryker CMF will again notify implanting surgeons, risk managers and its sales representatives of this recall and its potential health risk and request that physicians or hospitals return to Stryker CMF any of this product that has not been implanted.
Physicians and patients with questions related to this issue should contact Stryker CMF at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET. Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Stryker Corporation is one of the world’s leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. For more information about Stryker, please visit www.stryker.com.
Patrick Anderson, Stryker Corporation
Aaron Kwittken, Kwittken & Company