Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy Recalled by Paragon 28, Inc. Due to Missing drill guide as stated in the package.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Paragon 28, Inc. directly.
Affected Products
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
Why Was This Recalled?
Missing drill guide as stated in the package.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Paragon 28, Inc.
Paragon 28, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report