ProLite Mesh - mesh recall
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical…
Why was ProLite Mesh - mesh 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code/REF 1010306-06 Lot Number/LOT: 412298
- Product
- ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical…
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 60 units
- Distribution
- Internationally to Spain only.
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)