Recall Z-1986-2025— Chamberlain Technologies LLC

Name: FDA recall Z-1986-2025
Creator: U.S. Food and Drug Administration
Published: 2022-08-12

Class II · Ongoing

Class II FDA medical device recall by Chamberlain Technologies LLC, initiated 2022-08-12. It names one FDA 510(k) clearance: K061445. Product: SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415. Reason: Potential presence of residual adhesive material on the mesh surface..

Recalling firm: Chamberlain Technologies LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-08-12
Firm location: Deer Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K061445 — SURGIMESH WNAspide Medical·cleared 2007-02-01

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

SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415

Reason for recall

Potential presence of residual adhesive material on the mesh surface.

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