Z-0480-2023Class II

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1

Name: Z-0480-2023 PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1
Creator: Ethicon, Inc.
Published: 2022-11-16
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2022-11-16 / Open, Classified

FDA source

Ethicon, Inc. began a recall of 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... on 2022-11-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0480-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-16
Posted: 2022-12-14
Recalling firm: Ethicon, Inc
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
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
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 root 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
Product codes and lots: UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0480-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0480-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-14

Product code NEW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)