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U.S. Department of Health and Human Services

Class 2 Device Recall TIGER Canulated Screw System

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 Class 2 Recall
TIGER Canulated Screw System
see related information
Date Posted April 26, 2010
Recall Status1 Terminated on May 03, 2010
Recall Number Z-1438-2010
Recall Event ID 55180
Premarket Notification
510(K) Number
K081510 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
Code Information Lot #0924081
Recalling Firm/
Manufacturer
Trilliant Surgical LTD
448 W 19th St Ste 366
Houston, Texas 77008-3914
Manufacturer Reason
for Recall
Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.
Quantity in Commerce 32 units
Distribution WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = TRILLIANT SURGICAL LTD
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