Z-1339-2018Class II

PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle

Name: Z-1339-2018 PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Creator: Ethicon, Inc.
Published: 2018-01-10
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2018-01-10 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle on 2018-01-10. FDA classified it as Class II and gives the reason as "Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1339-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-10
Posted: 2018-04-10
Terminated: 2019-04-11
Recalling firm: Ethicon, Inc
Product: PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2018. For further assistance contact 1-855-215-5039.
Quantity in commerce: 72
Distribution: Distribution US Nationwide, Canada, India, and Colombia.
Product codes and lots: Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1339-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1338-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1339-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1340-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

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