Reported Jun 13, 2018 · Terminated
Restoris MCK Onlay Insert Extractor.
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?
- Restoris MCK Onlay Insert Extractor.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 160430— — Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912. Expanded scope — Lot No. 19150517, 19160517. - Amount recalled
- 575 units total (400 US, 175 OUS)
Where it was sold
Why it was recalled
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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