PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximat

FDA device recall Z-0480-2023 · posted 2022-12-14 · Open, Classified

Recall details

Recalling firm

Ethicon, Inc.

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NEW

Quantity affected

7,560 eaches

Distribution

International (OUS) only: Canada, Japan, Australia and New Zealand

Date initiated

2022-11-16

Date posted

2022-12-14

Location

Somerville, NJ