TMINI Knee Instrument Array Guide May Bind During Surgical Drilling
A precision component in Think Surgical's TMINI robotic knee system may bind due to insufficient clearance. The binding could occur during surgical drilling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a surgical instrument component with a mechanical defect that could affect surgical procedure execution. While no injuries have been reported in the source text, the risk of binding in a precision surgical instrument during a critical procedure justifies a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Think Surgical, Inc. is recalling the Assembly, Array Guide TMINI (REF: 109101), a component of the TMINI Miniature Robotic System used in knee surgery. Sixteen units have been distributed nationwide to healthcare facilities in Alabama, Ohio, Nevada, Texas, Utah, California, and Missouri.
The component may experience galling (cold-welding due to friction) and subsequent binding between the array fixation pins and the array guide holes. This occurs due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the array guide holes. The binding could occur during the drilling phase of a surgical procedure.
Healthcare facilities using this component should verify their lot numbers against the affected list (2316701, 2232601, 23030, 2228501, 2327802, 22152) and contact Think Surgical, Inc. for guidance on replacement or safe disposal.
The recalled product
- Product
- Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
- Manufacturer
- Think Surgical, Inc.
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI-DI: M9461091010. Lot Numbers: 2316701
- 2232601
- 23030
- 2228501
- 2327802
- 22152
Distribution
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