Events

Recall of Nitinol Staple, Elastic Staple LargeAsymmetrical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TriMed 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
    80099
  • Event Risk Class
    Class 2
  • Event Number
    Z-2262-2018
  • Event Initiated Date
    2018-04-13
  • 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=164555
  • 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
    During a retrospective review of sterilization records, trimed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. sterilization records indicate that all lots of staples were irradiated to at least the defined dose. there is a risk that this issue could result in patient infection if not properly sterilized.
  • Action
    On 04/13/18, customer recall communication forms were sent via mail informing customers to quarantine effected devices, call the manufacturer to arrange device return at 800-633-7221, and report adverse events to the FDA's MedWatch.

Device

Nitinol Staple, Elastic Staple LargeAsymmetrical
  • Model / Serial
    Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ,  10505-23, 050523, 180502, 180901,  180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805,  180502,  118901
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
  • Product Description
    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
  • Manufacturer
    TriMed Inc.

Manufacturer

TriMed Inc.
  • Manufacturer Address
    TriMed Inc., 27533 Avenue Hopkins, Santa Clarita CA 91355-3910
  • Manufacturer Parent Company (2017)
    Trimed Incorporated
  • Source
    USFDA