Class 2 Device Recall PDS Plus Antibacterial (polydioxanone) Suture

• Date Initiated by Firm: March 31, 2023
• Date Posted: May 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1571-2023
• Recall Event ID: 92084
• 510(K)Number: K061037
• Product Classification: Suture, surgical, absorbable, polydioxanone - Product Code NEW
• Product: PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue.; Product Code: PDP9625H
• Code Information: UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH
• Recalling Firm/ Manufacturer: Ethicon, Inc.; 1000 Route 202; Raritan NJ 08869-1425
• Manufacturer Reason for Recall: Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
• FDA Determined Cause: Under Investigation by firm
• Action: Ethicon issued Urgent Field Safety Notice Voluntary Product Recall (Removal) Letter for Johnson & Johnson Affiliates in the countries to contact primary and secondary consignees and/or end customers. Letter issued via email 3/31/23, states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and return to MDFieldActionsUKirl@its.jnj.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. Customers are required to return unused PDS¿ Plus Antibacterial (polydioxanone) Suture products subject to this recall that are in inventory immediately. 7. To return product subject to this recall, please complete the declaration below advising of your contact and collection details and our returns team will contact you to arrange collection. If you require any assistance with returning product, please contact MDFieldActionsUKirl@its.jnj.com. If you have any further questions related to this notice or if you need any additional communications, please contact your local Sales Representative.
• Quantity in Commerce: 1,656 eaches (OUS only)
• Distribution: International distribution in the countries of United Kingdom, Ireland and Turkey.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NEW and Original Applicant = ETHICON, INC.