Z-0512-2009

Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI...

Name: Z-0512-2009 Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI...
Creator: Stryker Craniomaxillofacial Division
Published: 2008-10-24
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2008-10-24 / Terminated / root cause: manufacturing process

FDA source

Stryker Craniomaxillofacial Division began a recall of Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant... on 2008-10-24. The reason FDA records is "Lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0512-2009
Status: Terminated
Initiated: 2008-10-24
Posted: 2008-12-18
Terminated: 2009-12-31
Recalling firm: Stryker Craniomaxillofacial Division
Product: Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Product code: KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Reason for recall: Lack of assurance of sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and 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. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.
Quantity in commerce: 322 of all products.
Distribution: Nationwide Distribution.
Product codes and lots: All units.

Product code KKY

K043250Class IIStryker Patient Specific Polymer ImplantStryker Leibinger / cleared 2005-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)