PDS recallZ-0480-2023 · Ethicon, Inc. · initiated Nov 16, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0480-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 16, 2022
- Posted by the FDA
- Dec 14, 2022
- Recalling firm
- Ethicon, Inc.
- Quantity
- 7,560 eaches
- Product code
- NEW
- Distribution
- International (OUS) only: Canada, Japan, Australia and New Zealand
Product description
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 (models, lots, serial numbers)
UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PDS Z340HEthicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall66 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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