Atrium Medical recalls ProLite Mesh product code 1010306-06 with lot 412298 due to incorrect packaging configuration that may lead to improper use in hernia repairs.
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.
Atrium Medical is recalling ProLite Mesh surgical mesh product code 1010306-06 with lot number 412298 because it was incorrectly packaged. This could lead to improper use during hernia repairs or other surgical procedures.
The recall involves a packaging error where product code 1010306-04 was mistakenly placed inside packages labeled as 1010306-06. This incorrect configuration could lead to improper use during surgical procedures, potentially causing complications in hernia repairs or other soft tissue deficiencies.
Patients who received ProLite Mesh for hernia repair or similar procedures using product code 1010306-06 with lot number 412298 are affected. Surgeons and medical facilities using this specific product configuration are at highest risk.
Check for product code 1010306-06 with lot number 412298 on the packaging. The mesh is intended for hernia repair and other soft tissue deficiencies.
Verify the product code and lot number on the packaging to confirm if it matches 1010306-06 with lot 412298.
The recall indicates an incorrect packaging configuration that could lead to improper use, but the mesh itself is intended for hernia repairs. Consult your surgeon for specific safety concerns.
The recall does not specify a remedy, so check with your surgeon or medical facility to determine next steps.
Look for product code 1010306-06 with lot number 412298 on the packaging.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0712-2018 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0712-2018 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
