Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
FDA device recall Z-0492-2014 · posted 2013-12-13 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- Reason for recall
- The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
- Action taken
- Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 24
- Distribution
- Distributed in FL and MD.
- Date initiated
- 2013-09-19
- Date posted
- 2013-12-13
- Date terminated
- 2014-12-22
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLUMBUS REVISION KNEE SYSTEM (K122985) | Aesculap Implant System, Inc. | 2012-10-26 |
| COLUMBUS REVISION KNEE SYSTEM (K083772) | Aesculap Implant System, Inc. | 2009-06-04 |