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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