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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 Device Recall TIGER Canulated Screw Systemsee related information
Date Initiated by FirmApril 14, 2009
Date PostedApril 26, 2010
Recall Status1 Terminated 3 on May 03, 2010
Recall NumberZ-1438-2010
Recall Event ID 55180
510(K)NumberK081510 
Product Classification screw, fixation, bone - Product Code HWC
Product2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
Code Information Lot #0924081
FEI Number 3007420745
Recalling Firm/
Manufacturer		 Trilliant Surgical LTD
448 W 19th St Ste 366
Houston TX 77008-3914
For Additional Information Contact
800-495-2919
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
ActionFirm 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 Commerce32 units
DistributionWI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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