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.
FDA Recall Z-2261-2018 · Posted None
Advertisement
Recalling FirmParagon 28, Inc.
Recall StatusTerminated
Product CodeJDR
Date Initiated2017-12-19
Date Terminated2021-01-15
Product Quantity1,626
Reason for Recall
Missing drill guide as stated in the package.
Firm Action
The firm, Paragon 28 Inc. sent an "MEDICAL DEVICE RECALL" letter dated Dec 19, 2017 to their consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to immediately review their inventory to determine if they have the devices; if you have possession of any of the devices, you must ship entire kit back to Paragon 28 Inc., 96 Inverness Drive, E. ste 1; Englewood CO 80112.
If you have any questions, contact Senior Quality Manager at 720-643-1301 or email to: [email protected].
Root Cause
Error in labeling
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement