Recall
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.
Think Surgical, Inc. · 30 March 2018
- Status
- Recall terminated
- Why, in the FDA's words
- “There is a potential for the cutter head to detach from the cutter shaft.”
- Recall began
- 30 March 2018
- Company
- Think Surgical, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.