Recall Z-1984-2025— Chamberlain Technologies LLC

Name: FDA recall Z-1984-2025
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: K072974. Product: SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415. 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

K072974 — SURGIMESH XBAspide Medical·cleared 2008-08-18

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 XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

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.