Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Reported: September 29, 2021 Initiated: July 30, 2021 #Z-2488-2021
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.
Details
- Recalling Firm
- Paragon 28, Inc.
- Units Affected
- 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
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630. Recalled by Paragon 28, Inc.. Units affected: 14 drill bits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2488-2021.
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