FDA Recall
Terminated
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.
Recall: Z-0975-2014
·
Initiated December 6, 2013
Recall
- Recall Number
- Z-0975-2014
- Event Number
- 67384
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- KKY
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- December 6, 2013
- Posted
- February 12, 2014
- Terminated
- May 6, 2015
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002
Description
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.
Reason
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Action
Stryker Orthopaedics sent Urgent Medical Device Recall Notification letters/Product Recall Acknowledgement Forms dated 12/6/2013 to US branch/agency. surgeons, hospital risk managers, and sales representatives.
Distribution
Distributed in PA.
Quantity
one unit