Z-1571-2023Class II

PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended...

Name: Z-1571-2023 PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended...
Creator: Ethicon, Inc.
Published: 2023-03-31
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2023-03-31 / Open, Classified

FDA source

Ethicon, Inc. began a recall of 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... on 2023-03-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1571-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-31
Posted: 2023-05-10
Recalling firm: Ethicon, Inc
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
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
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 root 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 [email protected] 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 [email protected]. 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.
Product codes and lots: UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1571-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1571-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10

Product code NEW

K061037Class IIPds Plus Antibacterial SutureETHICON, Inc. / cleared 2006-07-14

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)