Class 2 Device Recall Ethicon PDS II (polydioxanone) Suture

• Date Initiated by Firm: November 16, 2022
• Date Posted: December 14, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0480-2023
• Recall Event ID: 91192
• Product Classification: Suture, surgical, absorbable, polydioxanone - Product Code NEW
• Product: PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
• Code Information: UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: SAME; 908-218-0707
• Manufacturer Reason for Recall: knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
• FDA Determined Cause: Under Investigation by firm
• Action: Ethicon notified the four impacted countries via "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" beginning Nov 16, 2022. Letter states reason for recall, health risk and actions to be taken. The customers were instructed to: 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 Ethicon, Inc. 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" II products subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall to Ethicon, Inc. Any non-affected product and any product returned after the date specified will not receive credit reimbursement. If you have any questions, call 908-218-0707.
• Quantity in Commerce: 7,560 eaches
• Distribution: International (OUS) only: Canada, Japan, Australia and New Zealand
• 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.