Recall Z-2261-2018 ยท JDR Staple, Fixation, Bone
Paragon 28, Inc.
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.
| Date | Dec 19, 2017 |
| Status | Terminated |
| Reason | Missing drill guide as stated in the package. |
| Root cause | Error in labeling |
| 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: epohl@paragon28.com. |
| Quantity | 1,626 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170923 | JAWS(TM) Nitinol Staple System Paragon 28, Jul 24, 2017 |