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U.S. Department of Health and Human Services

Class 2 Device Recall PDS" Plus Antibacterial Suture

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  Class 2 Device Recall PDS" Plus Antibacterial Suture see related information
Date Initiated by Firm June 08, 2018
Create Date July 24, 2018
Recall Status1 Terminated 3 on September 25, 2020
Recall Number Z-2533-2018
Recall Event ID 80401
510(K)Number K061037  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle
Product Code: PDP493G (GTIN 10705031203945)
Code Information Lot Number:MCZ162
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact SAME
908-218-0707
Manufacturer Reason
for Recall		 Products do not meet a tensile strength specification
FDA Determined
Cause 2		 Under Investigation by firm
Action Johnson & Johnson Affiliate Japan notified consignees on 6/08/18 by customer letter through post or email or sales representative visits. Accounts requested to Examine inventory, remove and quarantine such product(s) and complete the Business Reply Form (BRF). Product to requested to be returned.
Quantity in Commerce 756
Distribution Japan
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.
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