Phantom Hindfoot TTC/TC Nail System recallZ-2488-2021 · Paragon 28, Inc. · initiated Jul 30, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Paragon 28, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process change control
What the company is doing
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
Recall details
- Recall number
- Z-2488-2021
- Status
- Terminated
- Initiated by the company
- Jul 30, 2021
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 14 drill bits
- Product code
- HTW
- 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 description
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Code information (models, lots, serial numbers)
Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Phantom Hindfoot TTC/TC Nail System P99-110-4630Paragon 28, Inc. · BIT, DRILL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page