Recall Z-0070-2018 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
| Date | Apr 25, 2017 |
| Status | Terminated |
| Reason | A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel. |
| Root cause | Nonconforming Material/Component |
| Action | The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned. |
| Quantity | 1 |
| Distribution | This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.