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
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.
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