Recall Z-0712-2018— Atrium Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2017-11-22, terminated 2018-07-30. It names one FDA 510(k) clearance: K151437. 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..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-22
- Terminated
- 2018-07-30
- Firm location
- Merrimack, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.