Recall Z-2605-2018— Think Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Think Surgical, Inc., initiated 2018-03-30, terminated 2020-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: There is a potential for the cutter head to detach from the cutter shaft..
- Recalling firm
- Think Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-30
- Terminated
- 2020-01-24
- Firm location
- Fremont, CA, United States
Product description
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.
Reason for recall
There is a potential for the cutter head to detach from the cutter shaft.
Data sourced from openFDA. This site is unofficial and independent of the FDA.