Events

Recall of Device Recall Monoswift

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CP Medical 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
    76875
  • Event Risk Class
    Class 2
  • Event Number
    Z-1872-2017
  • Event Initiated Date
    2017-02-02
  • 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=154457
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Reason
    The tensile strength minimum as directed by usp <881> was not met over the length of the product's shelf life.
  • Action
    The affected distributors/customers were contacted directly via telephone or by e-mail on February 6-7, 2017. Those end users not contacted by CP Medical directly will be contacted by their distributor

Device

Device Recall Monoswift
  • Model / Serial
    Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, WA and South Africa
  • Product Description
    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
  • Manufacturer
    CP Medical Inc

Manufacturer

CP Medical Inc
  • Manufacturer Address
    CP Medical Inc, 1775 Corporate Dr Ste 150, Norcross GA 30093-2960
  • Source
    USFDA