Health product recall

ETHIBOND EXCEL® , ETHIBOND®, PERMAHAND®, PROLENE® sutures

Brand(s)
Last updated

Summary

Product
ETHIBOND EXCEL® , ETHIBOND®, PERMAHAND®, PROLENE® sutures
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

ETHIBOND® Extra Polyester Suture

103H4B

X425H

PROLENE® Suture - Taper Point

103E22

8706H

PERMAHAND® Non Absorbable Silk Suture

10386S
103DBT

623H
K872H

ETHIBOND EXCEL® Polyester Suture

103ELK

X872H

Issue

An open seal defect was detected during internal rework activities. Investigation determined that the preliminary cause of issue was a machine failure, leading to the zipper tray to be incorrectly positioned in the copolymer pre-formed cavity and subsequent tray misalignment with the front seal area in the sealing process. This ultimately resulted in possibility of open seal condition and/or narrow seal defects in the subsequent units.

Recall start date: December 30, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Ethicon LLC

475 C Street, Suite 401, Guaynabo, Puerto Rico, United States, 00969

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76812

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