ProLite Mesh — Class II medical device recall Z-0712-2018
Terminated recall by Atrium Medical Corporation, reported 2018-03-07. An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLi
| Recall number | Z-0712-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2017-11-22 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-07-30 |
| Countries outside the US | ES |
| Quantity | 60 units |
| Reason classes | labeling |
| Lot numbers | 412298 |
| Model numbers | 1010306-06 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0712-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.