FDA Device recall Z-2745-2020
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
- FDA Device
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 by Mako Surgical, citing characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2745-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-09 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mako Surgical |
| Distribution | AZ, CA, FL, MN, NY, RI, TN, TX |
Product
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Reason
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Identifiers
| code_info | UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167…UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167(21)1905352; (01)00848486022167(21)1905369; (01)00848486022167(21)1905387; (01)00848486022167(21)1905383; (01)00848486022167(21)1905353; (01)00848486022167(21)1905356; (01)00848486022167(21)1905357; (01)00848486022167(21)1905365; (01)00848486022167(21)1905388; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2745-2020%22
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