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Regeneten tendon anchors (8)
Official notice
29 Aug 2024
Last checked
29 Aug 2024
An official Health Canada notice concerns Regeneten tendon anchors (8). There is a potential for a sterile barrier breach due to a packaging issue. Specifically, an issue identified in the product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner tyvek pouch, which contains the sterile product. As a result of the breached foil pouch, the sterile field may be contaminated by the outside of the inner pouch. Recall Start Date: August 12, 2024 Published 2024-08-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75986
Official notice
2024-08-29
The hazard
The hazard
There is a potential for a sterile barrier breach due to a packaging issue. Specifically, an issue identified in the product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner tyvek pouch, which contains the sterile product. As a result of the breached foil pouch, the sterile field may be contaminated by the outside of the inner pouch. Recall Start Date: August 12, 2024
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
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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: Smith Nephew Endoscopy, Regeneten Tendon Anchors.
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.
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