PDS II (Polydiaxanone) Absorbable Suture
Brand(s)
Summary
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 |
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
Ethicon LLC
475 C Street, Suite 401, Guaynabo, Puerto Rico, United States, 00969