No image published for this recall
Pds (polydioxanone) monofilament suture
Official notice
25 Nov 2022
Last checked
25 Nov 2022
An official Health Canada notice concerns Pds (polydioxanone) monofilament suture. 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 Published 2022-11-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72216
Official notice
2022-11-25
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
Checked manually this time?
The app alerts you when a new official recall is published — no searching, no checking back.
Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Ethicon, Pds Monofilament Suture.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
View full official noticeWeekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 25 Nov 2022. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
