Trilliant Surgical Ltd.: Medical Device Recall in 2015 - (Recall #: Z-2421-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 20, 2015

Date Posted: August 26, 2015

Recall Number: Z-2421-2015

Event ID: 71783

Reason for Recall:

The cutting efficiency of the Countersinks was out of specification.

Status: Terminated

Product Quantity: 102 units

Code Information:

Lot numbers 1362-01 and 1364-01

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated