ETHIBOND EXCEL® , ETHIBOND®, PERMAHAND®, PROLENE® sutures
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
623H |
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
Ethicon LLC
475 C Street, Suite 401, Guaynabo, Puerto Rico, United States, 00969
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