medical Class II Updated 2018-06-27

Paragon 28, Inc. recalls P28 JAWS Nitinol Staple System kits are designed for use in

Recalled 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.


Hazard / Issue

Missing drill guide as stated in the package.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →