Z-2534-2018Class II

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle

Name: Z-2534-2018 PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle
Creator: Ethicon, Inc.
Published: 2018-06-08
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2018-06-08 / Terminated

FDA source

Ethicon, Inc. began a recall of PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347) on 2018-06-08. FDA classified it as Class II and gives the reason as "Products do not meet a tensile strength specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2534-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Posted: 2018-07-24
Terminated: 2020-09-25
Recalling firm: Ethicon, Inc
Product: PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Products do not meet a tensile strength specification
FDA root cause: Under Investigation by firm
Action: Johnson & Johnson Affiliate Japan notified consignees on 6/08/18 by customer letter through post or email or sales representative visits. Accounts requested to Examine inventory, remove and quarantine such product(s) and complete the Business Reply Form (BRF). Product to requested to be returned.
Quantity in commerce: 72
Distribution: Japan
Product codes and lots: Lot Number: MCZ363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2534-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2532-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-24
Z-2533-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-24
Z-2534-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)