Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Summary
The FDA issued a Class II for Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 by Paragon 28, Inc.. 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.
Details
Source
Device Recall
External ID
Z-2488-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Lot/Code Info: Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550
Quantity Affected: 14 drill bits
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-30
Company
Englewood, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Paragon 28, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Paragon 28, Inc. have FDA actions?
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2488-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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