Mako Surgical Corporation: Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

Is my product affected?

Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

• UPC 00848486022167

Check against the official notice below — it lists the full affected range.

What happened

Mako Surgical Corporation is recalling 12 units of the Mako Hip End Effector, Variable Angle (catalog number 206967) due to a characterization issue with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. The affected units were distributed to medical facilities in Texas, Minnesota, California, Rhode Island, Florida, New York, Arizona, and Tennessee.

The recall involves 12 specific lot codes identified by their UDI numbers. The source document does not specify a remedy or corrective action for affected consumers or healthcare providers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

Details from the source

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: TX, MN, CA, RI, FL, NY, AZ, TN Quantity: 12 units Lot/code info: 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;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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