FDA Medical devices recall ·
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail recall
- Recall number
- Z-0871-2026
- Date
- (initiated October 13, 2025)
- Company / brand
- Paragon 28, Inc.
14445 Grasslands Dr, Englewood, CO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Distribution
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
States: California Florida Illinois Louisiana Maryland New Jersey New Mexico Nevada New York Ohio Tennessee Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0871-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.