FDA Device recall Z-0070-2018
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee
- FDA Device
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee by Zimmer Biomet, citing 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 surg….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0070-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-25 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | n/a |
Product
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
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.
Identifiers
| code_info | Part Number: CP116574 Lot Number: 073840 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2018%22
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