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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