Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Co
FDA device recall Z-0975-2014 · posted 2014-02-12 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KKY
- Quantity affected
- one unit
- Distribution
- Distributed in PA.
- Date initiated
- 2013-12-06
- Date posted
- 2014-02-12
- Date terminated
- 2015-05-06
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K103010) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-10-26 |