Recall Z-0319-2025— Ethicon, Inc.

Name: FDA recall Z-0319-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-25

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2024-09-25. It names one FDA 510(k) clearance: K183183. Product: Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H. Reason: Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-25
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K183183 — VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.·cleared 2019-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

Reason for recall

Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

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