Events

Recall of Device Recall MANI Needle and Suture Pack PGA Absorbable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mani, Inc. - Kiyohara Facility.

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
    60225
  • Event Risk Class
    Class 2
  • Event Number
    Z-0650-2012
  • Event Initiated Date
    2011-07-20
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105995
  • 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
    Surgical sutures may be weak and may not function as intended during surgical procedures.
  • Action
    The manufacturer notified consignees by phone, via fax with a letter, and e-mail on 07/20/11. The letter asked customers to check their inventory for any of the affected product, and if they had any product remaining to place the amount in the list "Returned." If there was no product left, then the amount used should be placed in the list "Used." Customers needed to complete and sign the document, being sure to send it and any remaining product to the address provided. Credit would be issued once goods were received. If customers have questions, they should contact the firm.

Device

Device Recall MANI Needle and Suture Pack PGA Absorbable
  • Model / Serial
    Z098004500, Z098004800, Z098007200, Z108002501, and Z108006900.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- PA and FL.
  • Product Description
    MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** || For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
  • Manufacturer
    Mani, Inc. - Kiyohara Facility

Manufacturer

Mani, Inc. - Kiyohara Facility
  • Manufacturer Address
    Mani, Inc. - Kiyohara Facility, 8-3 Kiyohara Industrial Park, Utsunomiya-shi, Tochigi-ken Japan
  • Manufacturer Parent Company (2017)
    Mani Inc.
  • Source
    USFDA