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Recall Observatory FDA recall evidence

Device product

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

Z-0533-2021

October 23, 2020

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 86631
Status
Terminated
Classification
Class II
Quantity
295 units distributed. Only 15 units are being recalled.
Official record key
device-enforcement:Z-0533-2021

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.