Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S
Summary
The FDA issued a Class II for Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, by Think Surgical, Inc.. 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.
Details
Source
Device Recall
External ID
Z-1318-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Lot/Code Info: UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
Quantity Affected: 16
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
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-12
Company
Fremont, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Think Surgical, Inc. has 11 FDA actions in our database, including 1 recall and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Think Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Think Surgical, Inc. have FDA actions?
Think Surgical, Inc. has 11 FDA actions in our database, including 1 recall and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1318-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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