Atrium Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-0712-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 22, 2017

Date Posted: March 7, 2018

Recall Number: Z-0712-2018

Event ID: 79293

Reason for Recall:

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.

Status: Terminated

Product Quantity: 60 units

Code Information:

Product Code/REF 1010306-06 Lot Number/LOT: 412298

Distribution Pattern:

Internationally to Spain only.

Voluntary or Mandated:

Voluntary: Firm initiated