• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures see related information
Date Initiated by Firm January 10, 2018
Create Date April 10, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall Number Z-1340-2018
Recall Event ID 79541
510(K)Number K061037  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product PDS Plus Antibacterial (Polydioxanone) Suture
Size 0 PDS Plus Violet 36
Single Armed CTB-1 Needle
Code Information Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
Recalling Firm/
Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 180
Distribution Distribution US Nationwide, Canada, India, and Colombia.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NEW and Original Applicant = ETHICON, INC.