Regeneten Tendon Anchors (8)
Brand(s)
Last updated
Summary
Product
Regeneten Tendon Anchors (8)
Issue
Medical devices - Sterility
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 |
|---|---|---|
| Regeneten Tendon Anchors (8) | More than 10 numbers, contact manufacturer. | 72205201 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Smith & Nephew, Inc. Endoscopy
150 Minuteman Road, Andover, Massachusetts, United States, 01810
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75986
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