Z-1773-2022Class II

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release...

Name: Z-1773-2022 PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release...
Creator: Ethicon, Inc.
Published: 2022-08-08
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2022-08-08 / Open, Classified / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles on 2022-08-08. FDA classified it as Class II and gives the reason as "Product may contain the incorrect material which could impact treatment". 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-1773-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-08
Posted: 2022-09-20
Recalling firm: Ethicon, Inc
Product: PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Product may contain the incorrect material which could impact treatment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customer notification began August 8, 2022. The responsible Johnson & Johnson affiliates in Japan will be contacting all their impacted primary and secondary consignees and/or end customers. Customers are asked to immediately check inventory for impacted product and to quarantine that product. In the event product has been forwarded to another facility, the customer shall contact that facility to arrange return. The customer shall complete the Business Reply Form (BRF) to confirm receipt of the recall notice within 3 business days. Customers are required to return unused impacted product per the recall letter instructions.
Quantity in commerce: 88 boxes (1056 ea)
Distribution: Distribution in Japan only
Product codes and lots: UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1773-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1773-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)