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Paragon 28, Inc. recalls P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and
Recalled June 27, 2018 · FDA recall Z-2261-2018 · Paragon 28
Hazard
Missing drill guide as stated in the package. · FDA Class II
Units
1,626
Sold at
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.
Description
Missing drill guide as stated in the package.
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.
Manufacturer(s)
Paragon 28, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →