Paragon 28, Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
Paragon 28, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (10)
FDA medical device enforcement actions by Paragon 28, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 13, 2025 | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S | Fibula nail system intended for use in fixation of fibular fractures and oste... | Class II |
| Dec 21, 2023 | Phantom TTC Nail, 10.0 X 200mm, Right | Medical devices distributed, prior to sterilization | Class II |
| Dec 21, 2023 | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L | Medical devices distributed, prior to sterilization | Class II |
| Dec 21, 2023 | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R | Medical devices distributed, prior to sterilization | Class II |
| Jul 13, 2022 | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-... | Suture anchor may break upon insertion, which could lead to potential debris ... | Class II |
| May 26, 2022 | HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) | Due to Titanium plasma coating not present implant. | Class II |
| May 18, 2022 | Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-28... | Incorrect labeling; There is potential that the drill packaging contains the... | Class II |
| Jul 30, 2021 | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection ... | A thin wall condition between the inner cannulation and the flutes of the dri... | Class II |
| Sep 28, 2018 | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type:... | It has been determined that the wedge implant kit is permanently mislabeled w... | Class II |
| Dec 19, 2017 | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, art... | Missing drill guide as stated in the package. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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