Z-1513-2025Class II

Pdsplusvio30in(75cm)usp6-0(M0.7)d/ac-1Mp

Name: Z-1513-2025 Pdsplusvio30in(75cm)usp6-0(M0.7)d/ac-1Mp
Creator: Ethicon Endo Surgery, LLC
Published: 2025-03-07
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2025-03-07 / Open, Classified / root cause: manufacturing process

FDA source

Ethicon Endo Surgery, LLC began a recall of PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP on 2025-03-07. FDA classified it as Class II and gives the reason as "Identified curing issues with the silicone during the needles manufacturing process". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1513-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-07
Posted: 2025-04-03
Recalling firm: Ethicon Endo-Surgery Inc
Product: Pdsplusvio30in(75cm)usp6-0(M0.7)d/ac-1Mp
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Identified curing issues with the silicone during the needles manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 7, 2025, "URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated March 7, 2025, were sent to customers. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 866-209-0985 or email [email protected] to Sedgwick within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to immediately return all unused sutures subject to this recall that are in inventory no later than June 30, 2025, to Sedgwick. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assistance with returning product, please contact Sedgwick at 866-737-4762 and reference Event # 8403. If you have additional questions regarding this communication or want to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.
Quantity in commerce: 792 units
Distribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
Product codes and lots: Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1513-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1514-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1515-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1516-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03

Product code NEW

K183183Class IIVICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. / cleared 2019-06-27

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)