Recall Z-1318-2024 · OLO Orthopedic Stereotaxic Instrument
Think Surgical, Inc.
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
| Date | Mar 20, 2024 (initiated Feb 12, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 productreturns@thinksurgical.com Customers with questions can contact the firm via phone at 510-249-2300, Option 1 |
| Quantity | 16 |
| Distribution | US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230202 | TMINI Miniature Robotic System THINK Surgical, Inc., Apr 25, 2023 |