Device product
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Z-0975-2014
Product summary
- Event
- Event 67384
- Status
- Terminated
- Classification
- Class II
- Quantity
- one unit
- Official record key
device-enforcement:Z-0975-2014
Official wording
Reason: Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Code information: 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
Distribution pattern: Distributed in PA.
Derived failure modes
-
Unknown
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.