Manufacturer
13 recalls in our database name Paragon 28, Inc. as the manufacturing or recalling firm.
Of the 13 recalls from Paragon 28, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.
Paragon 28 is recalling 20 Phantom Fibula Nails because out of specification thread depths may prevent the implant from mating with its mounting bolt, potentially requiring surgery to be aborted.
Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.
Paragon 28, Inc. is recalling the Phantom TTC Nail (10.0 X 150mm, RIGHT) distributed in California, as these devices were shipped prior to sterilization. Unsterilized surgical implants pose a serious risk of infection and complications.
Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.
Paragon 28, Inc. is recalling Grappler Suture Anchors (REF: P44-110-3010-SK, Lot 5007499) due to risk that the anchor may break upon insertion, potentially leaving debris in patients and delaying surgery.
Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.
Paragon 28, Inc. has recalled Baby Gorilla/Gorilla Plating System drills (Ref: P99-100-2816) because the drill packaging may contain incorrect part numbers.
Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.
Paragon 28, Inc. is recalling 64 Titan 3-D Wedge implant kits because they are permanently mislabeled with the wrong size, which could cause surgical delays.
Paragon 28, Inc. is recalling P28 JAWS Nitinol Staple System kits because the drill guide is missing from the package.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Paragon 28 (United States)
company in Englewood, United States
Source: Wikidata (Q104481348), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.