Mako Hip End Effector recall
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Why was Mako Hip End Effector recalled?
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 12 units
- Distribution
- TX, MN, CA, RI, FL, NY, AZ, TN
- Recall date
- August 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)