Ethicon, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0533-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 23, 2020

Date Posted: December 9, 2020

Recall Number: Z-0533-2021

Event ID: 86631

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.

Status: Terminated

Product Quantity: 295 units distributed. Only 15 units are being recalled.

Code Information:

Product Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated