P28 JAWS Nitinol Staple System kits are designed for use in an… — Class II medical device recall Z-2261-2018
Terminated recall by Paragon 28, Inc., reported 2018-06-27, distributed nationwide. Missing drill guide as stated in the package.
| Recall number | Z-2261-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2017-12-19 |
| Classified | 2018-06-20 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2021-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ZA |
| Quantity | 1,626 |
| Lot numbers | 260315217A, 260315217B, 260317717A, 260317717B, 260317717C, 260322017A, 260322017B, 260322017C, 260322017D, 260322017E, 260322017F, 260322017G, 260326217A, 260326217B, 260326217D, 260326217E, 260326217F, 260326217G, 260326217M |
| Model numbers | 10MM, 8MM, P71-008-0808-S, P71-010-1010-S, P71-108-0808-S, P71-110-1010-S |
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.
Reason for recall
Missing drill guide as stated in the package.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2261-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.