Think Surgical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2605-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 30, 2018

Date Posted: August 15, 2018

Recall Number: Z-2605-2018

Event ID: 80091

Reason for Recall:

There is a potential for the cutter head to detach from the cutter shaft.

Status: Terminated

Product Quantity: 951

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.

Voluntary or Mandated:

Voluntary: Firm initiated