CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report
Phantom Fibula Nail, Right, Ti, Fibula Nail recalled by Paragon 28
Paragon 28 is recalling Phantom Fibula Nail, Right, Ti, Fibula Nail, distributed nationwide in the US. The recall was initiated on 13 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0871-2026
- FDA event ID
- 97891
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Oct 2025
- FDA classified
- 2 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 13 Oct 2025 | Recall initiated by company | |
| 2 Dec 2025 | Classified by FDA | +50 days |
| 10 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Where it was distributed
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Nationwide CaliforniaFloridaIllinoisLouisianaMarylandNew JerseyNew MexicoNevadaNew YorkOhioTennesseeTexasWashington
Questions about this recall
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.
Which lots are affected?
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Where was it sold?
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Paragon 28
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Nominal Right recalled | Paragon 28 | Other | Nationwide |
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Small Right recalled | Paragon 28 | Other | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Phantom TTC Nail, 10.0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
| Device | CLASS II | Phantom TTC Nail, TTC Nail, 10.0, Right recalled by Paragon 28 | Paragon 28 | Sterility | CA |
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