Z-0871-2026Class II

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Name: Z-0871-2026 Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Creator: Paragon 28, Inc.
Published: 2025-10-13
License: https://open.fda.gov/license/

Paragon 28 / initiated 2025-10-13 / Open, Classified / root cause: design

FDA source

Paragon 28, Inc. began a recall of Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S on 2025-10-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0871-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-13
Posted: 2025-12-02
Recalling firm: Paragon 28
Product: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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]
Quantity in commerce: 20
Distribution: US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Product codes and lots: UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0871-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0871-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-02

Product code HSB

K234128Class IIPhantom Fibula Nail SystemParagon 28, Inc. / cleared 2024-08-22

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)