Events

Recall of Device Recall SurgiWrap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MAST Biosurgery USA, 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
    70051
  • Event Risk Class
    Class 2
  • Event Number
    Z-1076-2015
  • Event Initiated Date
    2014-08-26
  • Event Date Posted
    2015-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132886
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Reason
    The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. the printed expiration date was august of 2017, while the bar code date read as july 31, 2017. the correct expiration date was july 31, 2017.
  • Action
    MAST Biosurgery labeled 49 new envelopes and sent them to the distributor, and subsequently had the distributor remove the contents of the outer envelope (instructions for use and the foil pouches containing the product) and place them into the newly supplied and properly labeled outer envelopes provided by them. The distributor requested to send back the original 49 enveloped. The second batch of new labels was inspected and attached to the new outer envelope to create a properly labeled outer envelope prior to shipping. The firm requested that once the distributor replaced the product and the IFU into the newly labeled envelopes that they provide documentation that the product had been repackaged into the new envelopes. The distributor was also requested to verify that they did not ship any product to customers with the incorrect label. The firm had the distributor return the 49 improperly with the incorrect labels and the first set of "corrected" labels to them for destruction. Further questions call (858) 550-8050.

Device

Device Recall SurgiWrap
  • Model / Serial
    LOT 52804 2017-08
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to the country of China.
  • Product Description
    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm || (01) 18964050255027 || (17) 170731(10)52804 || LOT 52804 2017-08 REF25502-01 || Product is wrapped in a foil pouch that is then sealed into an additional envelope.
  • Manufacturer
    MAST Biosurgery USA, Inc

Manufacturer

MAST Biosurgery USA, Inc
  • Manufacturer Address
    MAST Biosurgery USA, Inc, 6749 Top Gun St Ste 108, San Diego CA 92121-4151
  • Manufacturer Parent Company (2017)
    Mast Biosurgery Usa Inc.
  • Source
    USFDA