FDA Enforcement
Class II
Ongoing
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Recall: Z-1318-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1318-2024
- Event ID
- 94086
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Think Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 27, 2024
- Initiation Date
- February 12, 2024
- Classification Date
- March 20, 2024
- Address
- 47201 Lakeview Blvd, Fremont, CA, 94538-6530, United States
Description
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
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.
Code Info
UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
Distribution
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Quantity
16