Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Class IIReported ongoing
Distribution: U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.
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 ...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
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 ...
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Checking Think Surgical, Inc.
Is there a recall on think surgical, inc. right now?
This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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