Events

Recall of Device Recall Drill guide for the JAWS Nitinol Staple System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Paragon 28, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80181
  • Event Risk Class
    Class 2
  • Event Number
    Z-2261-2018
  • Event Initiated Date
    2017-12-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164789
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Staple, fixation, bone - Product Code JDR
  • Reason
    Missing drill guide as stated in the package.
  • 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.

Device

Device Recall Drill guide for the JAWS Nitinol Staple System
  • Model / Serial
    Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-010-1010-S 10mm x 10mm x 10mm, Straight Lots 260317717A, 260317717C, 260322017B, and 260326217D., Part # P71-108-0808-S 8mm x 8mm x 8mm, Angled, Lots 260322017C, 260322017D, 260315217B, and 260326217M. and  Part # P71-110-1010-S 10mm x 10mm x 10mm, Angled Lots 260326217E,  260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    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
    Paragon 28, Inc.

Manufacturer

Paragon 28, Inc.
  • Manufacturer Address
    Paragon 28, Inc., 4B Inverness Ct E Ste 280, Englewood CO 80112-5329
  • Manufacturer Parent Company (2017)
    Paragon 28 Inc.
  • Source
    USFDA