Assembly, Array Guide TMINI, REF: 109101, part of the TMINI… recallZ-1318-2024 · Think Surgical, Inc. · initiated Feb 12, 2024
Class II Open, Classified All recalls posted in March 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Think Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1318-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 12, 2024
- Posted by the FDA
- Mar 20, 2024
- Recalling firm
- Think Surgical, Inc.
- Quantity
- 16
- Product code
- OLO
- FDA submissions
- K230202
- Distribution
- US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Product description
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Code information (models, lots, serial numbers)
UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
Other devices under the same FDA submission
5 devices cleared under K230202 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TMINI™ Robot 109343Think Surgical, Inc. · Orthopedic stereotaxic instrument11 reports
- TMINI™ Navigation Console 108757Think Surgical, Inc. · Orthopedic stereotaxic instrument4 reports
- TPLAN® Planning Station 109000Think Surgical, Inc. · Orthopedic stereotaxic instrument2 reports
- Tracking Array Bracket 109091Think Surgical, Inc. · Orthopedic stereotaxic instrument2 reports
- Tibia Tracking Array 109004Think Surgical, Inc. · Orthopedic stereotaxic instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page