Class II — Paragon 28, Inc.
| Recalling firm | Paragon 28 |
|---|---|
| Registered facility | PARAGON 28 (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to Titanium plasma coating not present implant. |
| Product | HammerTube Implant, 2.75mm, 10® Cannulated (Sterile) |
| Quantity | 9 implants |
| Distribution | U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY. |
| Initiated | 2022-05-26 |
| Classified | 2022-07-27 |
| Recall number | Z-1468-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Paragon 28, Inc. (Z-1468-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90436/
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