Device 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.
Z-2421-2015
Product summary
- Event
- Event 71783
- Status
- Terminated
- Classification
- Class II
- Quantity
- 102 units
- Official record key
device-enforcement:Z-2421-2015
Official wording
Reason: The cutting efficiency of the Countersinks was out of specification.
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.
Derived failure modes
-
Potency or specification failure
out of specification