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Think Surgical, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Think Surgical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-03-27FDA-DeviceClass IIAssembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
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