2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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.
This recall has been terminated (originally issued August 19, 2015).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- July 20, 2015
- Posted
- August 19, 2015
- Terminated
- January 26, 2017
- Recall Number
- Z-2421-2015
- Quantity
- 102 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The cutting efficiency of the Countersinks was out of specification.
Distribution
US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.
Lot / Code Info
Lot numbers 1362-01 and 1364-01
Root Cause
Nonconforming Material/Component
Action Taken
Trilliant sent an Important Medical Device Advisory Notice letter dated February 15, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers of the option to exchange affected instruments at no charge. To initiate the exchange customers were instructed to contact your local Trilliant Surgical Sales Representative, contact the Customer Service Department directly at 1-800-495-2919, or via email at orders@trilliantsurgical.com.