Health product recall

PDS (Polydioxanone) Monofilament Suture

Brand(s)
Last updated

Summary

Product
PDS (Polydioxanone) Monofilament Suture
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

PDS (Polydioxanone) Monofilament Suture

SCMSHK

Z340H

Issue

Returned representative unopened samples were evaluated for knot tensile strength and a portion of samples were observed to be significantly below the minimum knot tensile force requirement. Low suture tensile strength may result in poor performance of the impacted product. The intended benefit of tissue approximation and/or ligation may not be achieved or sustained. Because the knot tensile strength was observed to be significantly below the force requirement, there is a high likelihood that if this issue is present, it will result in breakage prior to use or intra-operatively rather than premature post-operative breakage.

Recall start date: November 15, 2022

Additional information

Details
Original published date: 2022-11-25
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies

Ethicon LLC

475 C Street, Suite 401, Guaynabo, Puerto Rico, United States, 00969

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72216