Recall Z-1936-2013— Atrium Medical Corporation

Name: FDA recall Z-1936-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-19

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2013-07-19, terminated 2016-03-18. It names one FDA 510(k) clearance: K050311. Product: C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.. Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions.

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-07-19
Terminated: 2016-03-18
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K050311 — ATRIUM MEDICAL CORPORATION C-QUR MESHAtrium Medical Corp.·cleared 2006-03-31

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

C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.

Reason for recall

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

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