Events

Recall of Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    79541
  • Event Risk Class
    Class 2
  • Event Number
    Z-1340-2018
  • Event Initiated Date
    2018-01-10
  • 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=162610
  • 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, surgical, absorbable, polydioxanone - Product Code NEW
  • Reason
    Three (3) lots were distributed with the incorrect expiry date on the label. the lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
  • Action
    On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2018. For further assistance contact 1-855-215-5039.

Device

Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures
  • Model / Serial
    Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution US Nationwide, Canada, India, and Colombia.
  • Product Description
    PDS Plus Antibacterial (Polydioxanone) Suture || Size 0 PDS Plus Violet 36 || Single Armed CTB-1 Needle
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., Us Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA