FDA Device recall Z-0712-2018
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or… by Atrium Medical, citing 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 pla….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0712-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-22 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atrium Medical |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Product Code/REF 1010306-06 Lot Number/LOT: 412298 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0712-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.