Mako Hip End Effector — Class II medical device recall Z-2745-2020
Terminated recall by Mako Surgical Corporation, reported 2020-08-12, distributed in AZ, CA, FL, MN, NY, RI, TN, TX. Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation
| Recall number | Z-2745-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2020-07-09 |
| Classified | 2020-07-31 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2023-06-16 |
| Distributed | AZ, CA, FL, MN, NY, RI, TN, TX |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 00848486022167 |
| Model numbers | 206967 |
Product
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Reason for recall
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
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-2745-2020. 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.