FDAOctober 13, 2025device
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
paragon 28paragon
UPCs
00889795133670501182207125
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhantom TTC Nail, 10.0 X 200mm, Right2023-12-21
- FDAPhantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R2023-12-21
- FDAPhantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L2023-12-21
- FDAISee Ortho-K Lens2023-06-26
- FDAFargo Ortho-K Lens2023-06-26
- FDAGrappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System2022-07-13
- FDAHammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)2022-05-26
- FDAParagon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm2022-05-18
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