Z-2716-2026Class II

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI...

Name: Z-2716-2026 TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI...
Creator: Think Surgical, Inc.
Published: 2026-05-08
License: https://open.fda.gov/license/

Think Surgical Inc. / initiated 2026-05-08 / Open, Classified / root cause: manufacturing process

FDA source

Think Surgical, Inc. began a recall of TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is... on 2026-05-08. FDA classified it as Class II and gives the reason as "Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2716-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-08
Posted: 2026-07-09
Recalling firm: Think Surgical Inc.
Product: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A "MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that THINK Surgical Incorporated is voluntarily notifying you of a potential defect in its Tracking Arrays (Femur and Tibia). THINK Surgical Incorporated has become aware that the tracking arrays may become loose. There have been 11 complaints regarding loose tracking arrays. if a Tracking Array is loose and moves when attached to the Tracking Array Bracket, it could result in incorrect positional information communicated to the system, potentially impacting system accuracy. Customers are instructed to: Prior to each use of any tracking array, the user should confirm that the tracking array is rigidly fixed in place and not loose when attached to the tracking array bracket. If the tracking array is loose, please use a replacement tracking array. -Fill out the accompanying Acknowledgement Form. Email the completed Acknowledgement Form to THINK Surgical, Inc at [email protected]. - Examine their inventory of tracking arrays and inspect them before each use. Please see Appendix 1 attached for instructions to perform the inspection method. - THINK Surgical Incorporated will provide customers with a Returned Material Authorization Form (RMA), a FedEx Envelope and return Fedex AirBill to return any affected devices. Customers will receive replacement unit(s). For Questions - Contact THINK Surgical Incorporated Customer Service at phone 833-878-4465 or [email protected].
Quantity in commerce: 360 devices
Distribution: U.S. Nationwide distribution in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA.
Product codes and lots: Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2716-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2716-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-09

Product code OLO

K260010Class IITMINI® Miniature Robotic SystemTHINK Surgical, Inc. / cleared 2026-03-03

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)