Phantom Fibula Nail System recallZ-0871-2026 · Paragon 28, Inc. · initiated Oct 13, 2025
Class II Open, Classified All recalls posted in December 2025
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
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
FDA root cause category: Device Design
What the company is doing
On 10/13/2025, recall notices were emailed to distributors who were asked to do the following: 1) Return affected devices to the firm using return label. 2) Ensure that in instances where you have distributed this affected product, that you forward this Recall Notification to your customers. 3) Replacements are available by contacting [email protected] Complaints can be directed to [email protected]
Recall details
- Recall number
- Z-0871-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Oct 13, 2025
- Posted by the FDA
- Dec 2, 2025
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 20
- Product code
- HSB
- FDA submissions
- K234128
- Distribution
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Product description
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Code information (models, lots, serial numbers)
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Phantom® Fibula Nail System P36-128-130R-SParagon 28, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall2 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K234128 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Phantom® Fibula Nail System P36-128-130L-SParagon 28, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
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 18, 2026. Text above is shown as published by the FDA.
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