Recall Z-0492-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Aesculap, Inc.
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
| Date | Dec 13, 2013 (initiated Sep 19, 2013) |
| Status | Terminated |
| Reason | The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. |
| Root cause | Component change control |
| Action | Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013. |
| Quantity | 24 |
| Distribution | Distributed in FL and MD. |
| FDA record | Open on fda.gov |