Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee — Class II medical device recall Z-0070-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-15. A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a su
| Recall number | Z-0070-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-04-25 |
| Classified | 2017-11-08 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2018-02-06 |
| Quantity | 1 |
| Lot numbers | 073840 |
| Model numbers | CP116574 |
Product
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0070-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.