FDA Device recall Z-2261-2018
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot…
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot… by Paragon 28, citing missing drill guide as stated in the package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2261-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-19 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Paragon 28 |
| Distribution | US |
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
Missing drill guide as stated in the package.
Identifiers
| code_info | Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-01…Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-010-1010-S 10mm x 10mm x 10mm, Straight Lots 260317717A, 260317717C, 260322017B, and 260326217D., Part # P71-108-0808-S 8mm x 8mm x 8mm, Angled, Lots 260322017C, 260322017D, 260315217B, and 260326217M. and Part # P71-110-1010-S 10mm x 10mm x 10mm, Angled Lots 260326217E, 260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.