Official recall record
Regeneten Tendon Anchors (8)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-08-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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