Z-1318-2024Class II

Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI...

Name: Z-1318-2024 Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI...
Creator: Think Surgical, Inc.
Published: 2024-02-12
License: https://open.fda.gov/license/

Think Surgical Inc. / initiated 2024-02-12 / Open, Classified / root cause: design

FDA source

Think Surgical, Inc. began a recall of Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System on 2024-02-12. FDA classified it as Class II and gives the reason as "There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1318-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-12
Posted: 2024-03-20
Recalling firm: Think Surgical Inc.
Product: Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/12/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine your inventory, locate any unused devices and quarantine them immediately. Your clinical representative(s) will assist with the recall process and provide guidance to your surgeon(s) for positioning the array fixation pins using the array bracket. 2) Do not use any affected product and return any used or unused product. 3) Complete and return the acknowledgment form to [email protected] Customers with questions can contact the firm via phone at 510-249-2300, Option 1.
Quantity in commerce: 16
Distribution: US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Product codes and lots: UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1318-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1318-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20

Product code OLO

K230202Class IITMINI™ Miniature Robotic SystemTHINK Surgical, Inc. / cleared 2023-04-25

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)