Z-1136-2019Class II

Pds II Suture 18"(45Cm) 2-0 Vio

Name: Z-1136-2019 Pds II Suture 18"(45Cm) 2-0 Vio
Creator: Ethicon, Inc.
Published: 2019-03-12
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2019-03-12 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular... on 2019-03-12. FDA classified it as Class II and gives the reason as "VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1136-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-12
Posted: 2019-04-12
Terminated: 2020-07-17
Recalling firm: Ethicon, Inc
Product: PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Ethicon notified primary and secondary US consignees via UPS second day between March 12-15,2019. Receipt of the letter confirmed via UPS tracking. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, Middle East. Latin America and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter describes the problem and action to take:Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). Remove the product subject to this voluntary recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. Do not open foil pouches to confirm contents. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. Customers are required to return unused impacted VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products subject to this recall (removal) that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall (removal) by July 31, 2019. Questions regarding this recall (removal) or to report any customer complaints,contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266), Monday through Friday, 7:30 AM to 6:30 PM ET. A Business Reply Form (BRF) asked to be completed and returned.
Quantity in commerce: 550,681 eaches (WW) Total
Distribution: Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
Product codes and lots: Lot Code: MGM110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1136-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1134-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12
Z-1135-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12
Z-1136-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)