FDA Recall Terminated

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.

Recall: Z-2605-2018 · Initiated March 30, 2018

Recall

Recall Number: Z-2605-2018
Event Number: 80091
Firm: Think Surgical, Inc.
FEI Number: 3000719653
Product Code: OLO
Status: Terminated
Root Cause: Process control
Initiated: March 30, 2018
Terminated: January 24, 2020
Address: 47201 Lakeview Blvd, Fremont, CA, 94538-6530

Description

Reason

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

Action

The firm, Think Surgical Inc., sent an "Urgent Medical Device Recall" notices dated 3/30/2018 to customers on 3/30/18. The notices instructed customers to perform the following actions: Examine your inventory, locate any unused devices noted above and quarantine them immediately. If you have received any accessory kits from THINK surgical Incorporated with the noted cutter part numbers included, do not use any affected product and return any unused product to the company. THINK Surgical Incorporated has provided you with a Returned Material Authorization Form (RMA), a FedEx Envelope and return FedEx AirBill to retun any unused devices. Your account will receive a credit and replacement units will be sent. Fill out the accompanying Acknowledgement Form. Email the completed Acknowledgement Form to Ms. Meliha Mulalic at [email protected]. Contact THINK Surgical Incorporated QA/RA Group at 510-249-2337, attention Ms. Meliha Mulalic, should you have any questions. Urgent Medical Device Recall Information: Lot Number Correction letters dated 4/4/18 were distributed as well. The letters corrected an error in the initial notification letter which alerted customers to a typographical error in which lot 9159 should read 9519.

Distribution

The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.

Quantity

951