Z-0712-2018 Class II Terminated
FDA device recall Z-0712-2018 was initiated by Atrium Medical Corporation on November 22, 2017 and is designated Class II. 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 pouc… The recall status is terminated (terminated July 30, 2018). Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- November 22, 2017
- Termination Date
- July 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
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.
Distribution Pattern
Internationally to Spain only.
Code Information
Product Code/REF 1010306-06 Lot Number/LOT: 412298