Ethicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2534-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)

Product Classification:

Class II

Date Initiated: June 8, 2018

Date Posted: August 1, 2018

Recall Number: Z-2534-2018

Event ID: 80401

Reason for Recall:

Products do not meet a tensile strength specification

Status: Terminated

Product Quantity: 72

Code Information:

Lot Number: MCZ363

Distribution Pattern:

Japan

Voluntary or Mandated:

Voluntary: Firm initiated