FDA recall Z-0533-2021

Product

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

Reason for recall

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

Distribution

The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements.

Key facts

Status

Terminated

Initiation date

2020-10-23

Report date

2020-12-09

Termination date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0533-2021