Z-2421-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2015
- Initiation Date
- July 20, 2015
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 units
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.
Reason for Recall
The cutting efficiency of the Countersinks was out of specification.
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.
Code Information
Lot numbers 1362-01 and 1364-01