PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 28, 2022 Initiated: August 8, 2022 #Z-1773-2022

Product Description

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

Reason for Recall

Product may contain the incorrect material which could impact treatment.

Details

Recalling Firm
Ethicon, Inc.
Units Affected
88 boxes (1056 ea)
Distribution
Distribution in Japan only
Location
Somerville, NJ

Frequently Asked Questions

What product was recalled?
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles. Recalled by Ethicon, Inc.. Units affected: 88 boxes (1056 ea).
Why was this product recalled?
Product may contain the incorrect material which could impact treatment.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 28, 2022. Severity: Moderate. Recall number: Z-1773-2022.