Recall Z-2532-2018— Ethicon, Inc.

Name: FDA recall Z-2532-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-08

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2018-06-08, terminated 2020-09-25. It names one FDA 510(k) clearance: K061037. Product: 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: Products do not meet a tensile strength specification.

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Terminated: 2020-09-25
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K061037 — PDS PLUS ANTIBACTERIAL SUTUREETHICON, Inc.·cleared 2006-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.