Reported Aug 12, 2020 · Terminated
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Davie, FL · 33317-7424
Is this the product you have?
- Mako Hip End Effector
- Variable Angle Catalog Number206967
- GTIN00848486022167
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 00848486022167(01)00848486022167(21)1905386 2 00848486022167(01)00848486022167(21)1905389 3 00848486022167(01)00848486022167(21)1905359 4 00848486022167(01)00848486022167(21)1905352 5 00848486022167(01)00848486022167(21)1905369 6 00848486022167(01)00848486022167(21)1905387 7 00848486022167(01)00848486022167(21)1905383 8 00848486022167(01)00848486022167(21)1905353 9 00848486022167(01)00848486022167(21)1905356 10 00848486022167(01)00848486022167(21)1905357 11 00848486022167(01)00848486022167(21)1905365 12 00848486022167(01)00848486022167(21)1905388 - Amount recalled
- 12 units
Where it was sold
Why it was recalled
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
This product could cause temporary or reversible health problems — stop using it.
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