Recall Z-1773-2022— Ethicon, Inc.

Name: FDA recall Z-1773-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-08

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2022-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles. Reason: Product may contain the incorrect material which could impact treatment..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-08
Firm location: Somerville, NJ, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.