Health product recall

PDS II (Polydiaxanone) Absorbable Suture

Brand(s)
Last updated

Summary

Product
PDS II (Polydiaxanone) Absorbable Suture
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalog number

PDS II (Polydiaxanone) Absorbable Suture

More than 10 numbers, contact manufacturer.

PDP442H
PDP497G

Issue

Ethicon received seven complaints for one lot of undyed PDS™ II sutures regarding low tensile strength. Internal testing on returned product from this lot confirmed that some PDS™ II sutures from this lot did not meet Ethicon's tensile strength requirement. An investigation identified additional lots across the PDS™ Plus Antibacterial and PDS™ II suture families that have the potential to be affected by the same root cause as the lot that received the complaints.

Recall Start Date: August 8, 2023

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
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-74132

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