FDAMay 18, 2022device
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
What to do
FDA enforcement status: Ongoing
Brands named
paragon 28paragon
UPCs
00889795053329
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S2025-10-13
- 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
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