Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
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.
From the FDA notice · Read the official notice ↗ · All Paragon 28 recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 20
- Illnesses reported
- None reported
- Manufactured in
- 14445 Grasslands Dr, Englewood, CO, United States
- Classification
- Class II
- Recall number
- Z-0871-2026
In the FDA's words
- Description
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S 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. 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. Affected quantity: 20
- Hazard
- 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.
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