Recall Z-2488-2021 ยท HTW Bit, Drill
Paragon 28, Inc.
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
| Date | Jul 30, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | On 08/12/2021, the Recalling Firm emailed to its distributors an "Medical Device Recall" Notification Letter inform them that it was identified that there is a thin wall condition between the inner cannulation and the flutes of the drill. At worst case, the defect is a fracture through the wall of the drill to the cannulation beneath. This feature is potentially nonconforming in some units within the lot identified below. The distributor was instructed to: 1) Immediately check its inventory and hospitals/health care facility within their region and to identify, discontinue use, quarantine and |
| Quantity | 14 drill bits |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.