Z-2532-2018 Class II Terminated

Recalled by Ethicon, Inc. — Somerville, NJ

Recall Details

Product Type
Devices
Report Date
August 1, 2018
Initiation Date
June 8, 2018
Termination Date
September 25, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4992

Product Description

PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)

Reason for Recall

Products do not meet a tensile strength specification

Distribution Pattern

Japan

Code Information

Lot Number: MBK743