Z-2488-2021 Class II Terminated
FDA device recall Z-2488-2021 was initiated by Paragon 28, Inc. on July 30, 2021 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 15, 2021). Affected quantity: 14 drill bits.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- July 30, 2021
- Termination Date
- December 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 drill bits
Product Description
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Reason for Recall
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.
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
Code Information
Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550