Z-2745-2020 Class II Terminated
FDA device recall Z-2745-2020 was initiated by Mako Surgical Corporation on July 9, 2020 and is designated Class II. Reason for recall: Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. The recall status is terminated (terminated June 16, 2023). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- July 9, 2020
- Termination Date
- June 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
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.
Distribution Pattern
TX, MN, CA, RI, FL, NY, AZ, TN
Code Information
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;