Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0712-2018

November 22, 2017

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 79293
Status
Terminated
Classification
Class II
Quantity
60 units
Official record key
device-enforcement:Z-0712-2018

Official wording

Reason: 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.

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

Distribution pattern: Internationally to Spain only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.