Events

Recall of Device Recall GalaSHAPE 3D

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

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
    75827
  • Event Risk Class
    Class 2
  • Event Number
    Z-0948-2017
  • Event Initiated Date
    2016-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151792
  • 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
    surgical film - Product Code OOD
  • Reason
    Endotoxin values from testing of retains slightly exceeded the established specification.
  • Action
    Tepha Medical Devices sent a Voluntary Product Recall Notification letter dated November 22, 2016, to all affected customers. Beginning on 11/21/2016, all impacted customers were notified of the recall via phone or in person by Galatea Surgical, a wholly owned subsidiary of Tepha, responsible for the sales and marketing of GalaSHAPE 3D. That notification was followed up by the Tepha recall letter dated November 22, 2016, delivered by certified mail. Customers were instructed to do the following: 1) Immediately review your inventory for the affected lot number listed above. 2) If you do not have any of the affected lot in your inventory, complete the enclosed Recall Acknowledgment Form, indicate that you have zero (O) inventory and fax the completed form back to (781) 357-1701 or email it to contact@galateasurgical.com. 3) If you do have inventory from the affected lot, please complete the enclosed Recall Acknowledgement Form and fax back to Tepha, Inc. at (781) 357-1701 or email it to contact@galateasurgical.com. A Galatea representative will contact you to arrange for the product return. If you have any questions or require assistance with the return of the recalled product, please call Galatea Surgical, at (781) 357-1752. For questions regarding this recall call 781-357-1750.

Device

Device Recall GalaSHAPE 3D
  • Model / Serial
    Lot Number: 160294
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to IN, CA, FL, MI, NV, and MT
  • Product Description
    GalaSHAPE 3D; product code SH3D03, a medium size oval || GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
  • Manufacturer
    Tepha Incorporated

Manufacturer

Tepha Incorporated
  • Manufacturer Address
    Tepha Incorporated, 99 Hayden Ave Ste 360, Lexington MA 02421-7966
  • Manufacturer Parent Company (2017)
    Tepha Inc.
  • Source
    USFDA