Paragon 28, Inc.
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 56
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0871-2026 | Class II | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S | October 13, 2025 |
| Z-1254-2024 | Class II | Phantom TTC Nail, 10.0 X 200mm, Right | December 21, 2023 |
| Z-1255-2024 | Class II | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L | December 21, 2023 |
| Z-1256-2024 | Class II | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R | December 21, 2023 |
| Z-1776-2022 | Class II | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the | July 13, 2022 |
| Z-1468-2022 | Class II | HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) | May 26, 2022 |
| Z-1458-2022 | Class II | Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless | May 18, 2022 |
| Z-2488-2021 | Class II | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 | July 30, 2021 |
| Z-0662-2020 | Class II | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (0 | September 28, 2018 |
| Z-2261-2018 | Class II | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment f | December 19, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253591 | Phantom® Hindfoot TTC/TC Nail System | March 5, 2026 |
| K253613 | Monkey Rings External Ring Fixation System | December 19, 2025 |
| K252106 | External Fixation Mini Rail System | September 30, 2025 |
| K251862 | External Fixation Bone Distractor | August 11, 2025 |
| K250952 | Baby Gorilla®/Gorilla® Plating System | July 18, 2025 |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | July 14, 2025 |
| K250641 | APEX 3D Total Ankle Replacement System | May 1, 2025 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | November 1, 2024 |
| K234128 | Phantom Fibula Nail System | August 22, 2024 |
| K241864 | Grappler Interference Screw System | July 25, 2024 |
| K240259 | APEX 3D Total Ankle Replacement System | June 24, 2024 |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | June 5, 2024 |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | March 26, 2024 |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | October 12, 2023 |
| K232838 | Monkey RingsTM External Fixation System | October 12, 2023 |
| K231496 | TITAN 3-D Wedge System | August 22, 2023 |
| K231867 | Grappler Suture Anchor System | August 21, 2023 |
| K230550 | JAWS Nitinol Staple System | May 11, 2023 |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | March 3, 2023 |
| K223056 | JAWS Nitinol Staple System | February 16, 2023 |