Public recall detail

PDS II (Polydiaxanone) Absorbable Suture

2023-08-18

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Recall Safety notice
Quick summary

Quick summary: PDS II (Polydiaxanone) Absorbable Suture. Date: 2023-08-18.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: PDS II (Polydiaxanone) Absorbable Suture. Date: 2023-08-18.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEthicon LLC
ProductPDS II (Polydiaxanone) Absorbable Suture
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74132

Affected products

ProductPDS II (Polydiaxanone) Absorbable Suture
LotMore than 10 numbers, contact manufacturer.
ModelPDP442H PDP497G
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPDS II (Polydiaxanone) Absorbable Suture

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesEthicon LLC 475 C Street, Suite 401, Guaynabo, Puerto Rico, United States, 00969
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74132
Background{}
CompaniesEthicon LLC 475 C Street, Suite 401, Guaynabo, Puerto Rico, United States, 00969
AudiencesGeneral public Healthcare Industry
Source updated2023-08-18

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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