Atrium Medical Corporation recalls ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia…

Recall date

November 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0712-2018

FDA classification

Class II

Brand / firm

Atrium Medical Corporation

Sold / distributed

Internationally to Spain only.

Why it was recalled

An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.