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U.S. Department of Health and Human Services

Class 2 Device Recall TMINI Array Guide Assembly

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  Class 2 Device Recall TMINI Array Guide Assembly see related information
Date Initiated by Firm February 12, 2024
Date Posted March 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1318-2024
Recall Event ID 94086
510(K)Number K230202  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Code Information UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
Recalling Firm/
Manufacturer		 Think Surgical, Inc.
47201 Lakeview Blvd
Fremont CA 94538-6530
For Additional Information Contact Jonathan Gibson
510-249-2300
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 16
Distribution US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = THINK Surgical, Inc.
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