Reported Aug 15, 2018 · Terminated
Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The…
Think Surgical, Inc.
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: Think Surgical, Inc. · 47201 Lakeview Blvd · Fremont, CA · 94538-6530
Is this the product you have?
- Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
- Lot codes and dates
Lot Numbers 915895199209923092699288983498691020110049616263039287956396429855989010313
- Amount recalled
- 951
Where it was sold
Why it was recalled
There is a potential for the cutter head to detach from the cutter shaft.
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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