FDANovember 22, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
atrium medicalatrium
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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