FDA Medical Device Recalls (openFDA)
Think Surgical, Inc.: 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 number
- Z-2605-2018
- Recalling firm
- Think Surgical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-03-30
- Posted
- not on file
- Terminated
- 2020-01-24
- Reason
- There is a potential for the cutter head to detach from the cutter shaft.
- Root cause
- Process control
- 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 mmulalic@thinksurgical.com. 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.
- Quantity
- 951
- Distribution
- The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
- Lot, serial or model codes
- Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3000719653
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28