Z-2488-2021Class II

Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

Name: Z-2488-2021 Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Creator: Paragon 28, Inc.
Published: 2021-07-30
License: https://open.fda.gov/license/

Paragon 28 / initiated 2021-07-30 / Terminated

FDA source

Paragon 28, Inc. began a recall of Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 on 2021-07-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2488-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-30
Posted: 2021-09-17
Terminated: 2021-12-15
Recalling firm: Paragon 28
Product: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Product code: HTW Bit, Drill
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.
FDA 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 not distribute any further the affected products. 2) Complete the Medical Device Recall Response Form and return to [email protected]. The form is to be completed and returned even if no physical product is in their possession. 3) Immediately return affected devices along with a copy of the Medical Device Recall Response Form to the Recalling Firm at Paragon28, Attn: Recalls, RN-008, 14445 Grasslands Dr., Englewood, CO 80112. For questions or further assistance - contact the Recalling Firm at: email - [email protected] or [email protected] Phone - 949-280-7688
Quantity in commerce: 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
Product codes and lots: Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2488-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2488-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-17

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)