Device product
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Z-0871-2026
Product summary
- Firm
- Paragon 28, Inc.
- Event
- Event 97891
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-0871-2026
Official wording
Reason: 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.
Code information: UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Distribution pattern: US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Derived failure modes
-
Potency or specification failure
out of specification