Phantom Nail System surgical drill recalled for fracture risk
Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or deaths. The hazard—potential fracture of a surgical drill—poses a risk of harm, but the source does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
Paragon 28, Inc. is recalling the Phantom Nail System surgical drill (Model P99-110-4630, Lot HN120550) due to a structural defect identified in the product.
The recalled drill has a thin wall condition between the inner cannulation and the flutes. This defect could potentially cause the drill to fracture through the wall to the cannulation beneath.
The recall affects 14 drill units distributed nationwide to surgical facilities in California, Florida, Georgia, Idaho, Kansas, Kentucky, Louisiana, Michigan, Missouri, North Carolina, New York, Texas, Virginia, Washington, and West Virginia.
Surgical facility administrators and users of this product should discontinue use and contact Paragon 28, Inc. for return or replacement instructions.
The recalled product
- Product
- Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
- Manufacturer
- Paragon 28, Inc.
- Affected units
- 14
Distribution
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