UnratedMedical device recall · FDA · Published November 22, 2017
Atrium Medical ProLite Mesh Recall: Incorrect Configuration Risk
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.
Take action
Contact the company
📍Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332
“Atrium Medical ProLite Mesh Recall: Incorrect Configuration Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72503-atrium-medical-prolite-mesh-recall-incorrect-configuration-risk. Based on FDA recall #Z-0712-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0712-2018%22&limit=1).
The FDA announced on Nov. 22, 2017, that Atrium Medical Corporation voluntarily recalled ProLite Mesh product code 1010306-06, lot number 412298. The recall addresses an incorrect mesh configuration packaged in the product. Distribution was limited to Spain.
How to tell if you have it
Brand: Atrium Medical
Product: ProLite Mesh
Product Code/REF: 1010306-06
Lot Number/LOT: 412298
The hazard
According to the FDA, an incorrect ProLite Mesh configuration was packaged as product code 1010306-06. Specifically, ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouches of packages labeled with product code 1010306-06 and lot number 412298.
Context
GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since Oct. 12, 2018. Other recent recalls of similar products include Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE (Feb. 16, 2026), Blom-Singer Classic Voice Prosthesis (June 17, 2026), and Medtronic Octopus 4 Tissue Stabilizer Model 29400 (May 12, 2026).
How to tell if you have this one
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.
Brand
Atrium Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code and lot number on the packaging to confirm if it matches 1010306-06 with lot 412298.
How this recall unfolded
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0712-2018 (November 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0712-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.