The Recall Desk
HighFDA (Devices)·Z-2488-2021·Announced 2021-09-29

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.

What this means for you

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.
Category
Medical Device — Orthopedic surgical instrument
Hazard
Affected units
14

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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