Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S
FDA device recall Z-1318-2024 · posted 2024-03-20 · Open, Classified
Recall details
- Recalling firm
- Think Surgical, Inc.
- 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.
- Action taken
- 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 productreturns@thinksurgical.com Customers with questions can contact the firm via phone at 510-249-2300, Option 1.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 16
- Distribution
- US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
- Date initiated
- 2024-02-12
- Date posted
- 2024-03-20
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TMINI™ Miniature Robotic System (K230202) | THINK Surgical, Inc. | 2023-04-25 |