FDADecember 19, 2017device
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Missing drill guide as stated in the package.
What to do
FDA enforcement status: Terminated
Brands named
paragon 28paragon
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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