FDA recall Z-0712-2018

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.

Distribution

Internationally to Spain only.

Key facts

Status

Terminated

Initiation date

2017-11-22

Report date

2018-03-07

Termination date

2018-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2018