Reported Mar 15, 2017 · Terminated
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
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 RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Product as published 204863THA 1.0 Application User Guide Part 207116THA 2.0 Application User Guide Part 208692THA 2.1 Application User Guide Part 209711MAKOplasty THA Application User Guide Part 210555MAKIplast THA 3.1 Application User Guide Part 212026THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part 204863THA 1.0 Application User Guide Part 207116THA 2.0 Application User Guide Part 208692THA 2.1 Application User Guide Part 209711MAKOplasty THA Application User Guide Part 210555MAKIplast THA 3.1 Application User Guide Part 212026THA Application User Guide - Amount recalled
- 777
Where it was sold
- Nationwide
Why it was recalled
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
This product could cause temporary or reversible health problems — stop using it.
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