Think Surgical, Inc. recalls Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The…
- Recall date
- March 30, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2605-2018
- FDA classification
- Class II
- Brand / firm
- Think Surgical, Inc.
- Sold / distributed
- The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
Why it was recalled
There is a potential for the cutter head to detach from the cutter shaft.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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