Recall Z-0107-04 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Plus Orthopedics
17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
| Date | Nov 13, 2003 (initiated Aug 1, 2003) |
| Status | Terminated |
| Reason | Plastic insert over articular surface of knee joint replacement may become dislodged. |
| Root cause | Other |
| Action | Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003. |
| Quantity | 35 |
| Distribution | AZ, ID, TX CTdistributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.