Atrium Medical Recalls ProLite Mesh Due to Incorrect Configuration Packaging
Atrium Medical is recalling 60 units of ProLite Mesh because the wrong mesh configuration was packaged in the pouch. The affected lots were distributed only to Spain.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries were reported, and the hazard is a packaging/configuration error rather than a direct contamination or defect causing harm.
Plain-English summary
Atrium Medical Corporation is recalling 60 units of ProLite Mesh, a surgical mesh used for soft tissue deficiencies including hernia repair and chest wall reconstruction. The recall is due to a packaging error where ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside pouches labeled with product code 1010306-06 and lot number 412298.
The affected product was distributed internationally to Spain only. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and patients should check their inventory for ProLite Mesh with product code 1010306-06 and lot number 412298. If found, the product should be quarantined and returned to Atrium Medical Corporation in accordance with the recall instructions.
The recalled product
- 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.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Mesh
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code/REF 1010306-06 Lot Number/LOT: 412298
Distribution
Distribution scope not specified by the agency.
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