Device 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.
Z-2605-2018
Product summary
- Event
- Event 80091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 951
- Official record key
device-enforcement:Z-2605-2018
Official wording
Reason: There is a potential for the cutter head to detach from the cutter shaft.
Code information: Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313
Distribution pattern: The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
Derived failure modes
-
Unknown
There is a potential for the cutter head to detach from the cutter shaft.