Class II — Paragon 28, Inc.
| Recalling firm | Paragon 28 |
|---|---|
| Registered facility | PARAGON 28 (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Missing drill guide as stated in the package. |
| Product | 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. |
| Quantity | 1,626 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa. |
| Initiated | 2017-12-19 |
| Classified | 2018-06-20 |
| Terminated | 2021-01-15 |
| Recall number | Z-2261-2018 |
| 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-2261-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80181/
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