Recall Z-0975-2014 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Stryker Howmedica Osteonics Corp.
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.
| Date | Feb 12, 2014 (initiated Dec 6, 2013) |
| Status | Terminated |
| Reason | Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. |
| Root cause | Labeling Change Control |
| 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. |
| Quantity | one unit |
| Distribution | Distributed in PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Oct 26, 2010 |