Z-2605-2018Class II

Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number...

Name: Z-2605-2018 Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number...
Creator: Think Surgical, Inc.
Published: 2018-03-30
License: https://open.fda.gov/license/

Think Surgical Inc. / initiated 2018-03-30 / Terminated / root cause: manufacturing process

FDA source

Think Surgical, Inc. began a recall of 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... on 2018-03-30. FDA classified it as Class II and gives the reason as "There is a potential for the cutter head to detach from the cutter shaft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2605-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Posted: 2018-08-06
Terminated: 2020-01-24
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: There is a potential for the cutter head to detach from the cutter shaft.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 951
Distribution: The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
Product codes and lots: Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2605-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2605-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-03

Product code OLO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)