Home / Recalls / Medical Devices
Trilliant Surgical Ltd. recalls 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-4
Recalled August 26, 2015 · FDA recall Z-2421-2015 · Trilliant Surgical
Hazard
The cutting efficiency of the Countersinks was out of specification. · FDA Class II
Units
102 units
Sold at
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.
Description
The cutting efficiency of the Countersinks was out of specification.
Product
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.
Manufacturer(s)
Trilliant Surgical Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →