Z-1318-2024 Class II Ongoing
FDA device recall Z-1318-2024 was initiated by Think Surgical, Inc. on February 12, 2024 and is designated Class II. 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 a… The recall status is ongoing. Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- February 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
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.
Distribution Pattern
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Code Information
UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152