Paragon 28, Inc. recalls P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones an…

Recall date

December 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2261-2018

FDA classification

Class II

Brand / firm

Paragon 28, Inc.

Sold / distributed

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.

Why it was recalled

Missing drill guide as stated in the package.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.