Paragon 28, Inc. Recall 88553
Description: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Paragon 28, Inc. Recall 88553 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2488-2021 |
| Event ID | 88553 |
| Event Description | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 14 drill bits |
| Recall 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. |
| Device Classification | 20210929 |
| Device Code Info | Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550 |
| Center Classification Date | 20210917 |
| Recall Initiation Date | 20210730 |
| Recalling Firm | Paragon 28, Inc. |
| Initial Notification | Letter |
| Similar To |