FDA Device recall Z-2605-2018
Think Surgical Cutter, Flat, ¿6.2mm x 144mm
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of Think Surgical Cutter, Flat, ¿6.2mm x 144mm by Think Surgical, citing there is a potential for the cutter head to detach from the cutter shaft.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2605-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-30 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Think Surgical |
| Distribution | NJ, NY, OH, TX |
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.
Reason
There is a potential for the cutter head to detach from the cutter shaft.
Identifiers
| code_info | Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2605-2018%22
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