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U.S. Department of Health and Human Services

Class 2 Device Recall Reamer Head

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  Class 2 Device Recall Reamer Head see related information
Date Initiated by Firm July 20, 2015
Date Posted August 24, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-2456-2015
Recall Event ID 71815
510(K)Number K121452  
Product Classification Reamer - Product Code HTO
Product Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.
Code Information TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708
Recalling Firm/
Manufacturer		 Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information Contact Customer Service
800-495-2919
Manufacturer Reason
for Recall		 The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
FDA Determined
Cause 2		 Component design/selection
Action The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments.
Quantity in Commerce 638 units
Distribution Nationwide throughout the US
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HTO and Original Applicant = TRILLIANT SURGICAL LTD
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