Z-0533-2021 Class II Terminated
FDA device recall Z-0533-2021 was initiated by Ethicon, Inc. on October 23, 2020 and is designated Class II. 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. The recall status is terminated (terminated December 21, 2022). Affected quantity: 295 units distributed. Only 15 units are being recalled..
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 23, 2020
- Termination Date
- December 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 295 units distributed. Only 15 units are being recalled.
Product Description
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 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.
Code Information
Product Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021