Device product
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Z-2488-2021
Product summary
- Firm
- Paragon 28, Inc.
- Event
- Event 88553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 drill bits
- Official record key
device-enforcement:Z-2488-2021
Official wording
Reason: A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Code information: Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550
Distribution pattern: U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A
Derived failure modes
-
Unknown
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.