Recalls / —
—#125375
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.
- FDA product code
- KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K103010
- Affected lot / code info
- 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
Why it was recalled
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 (FDA determination)
Labeling Change Control
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Distributed in PA.
Timeline
- Recall initiated
- 2013-12-06
- Posted by FDA
- 2014-02-12
- Terminated
- 2015-05-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125375. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.