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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated Drill Bit

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 Class 2 Device Recall Cannulated Drill Bitsee related information
Date Initiated by FirmJuly 20, 2015
Date PostedAugust 24, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall NumberZ-2452-2015
Recall Event ID 71812
510(K)NumberK081510 
Product Classification Bit, drill - Product Code HTW
Product3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Code Information Lot 1363-01
Recalling Firm/
Manufacturer		 Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information ContactCustomer Service Department
800-495-2919
Manufacturer Reason
for Recall		The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionTrilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at orders@trilliantsurgical.com.
Quantity in Commerce121 units
DistributionNationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
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 = HTW
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