BIORAPTOR™ Suture Anchors
Brand(s)
Last updated
Summary
Product
BIORAPTOR™ Suture Anchors
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 catalogue number |
---|---|---|
Bioraptor Curved 2.3 Pk Suture Anchor |
2151692 |
72203281 |
Bioraptor 2.3 Pk Suture Anchor W/Ultrabraid Suture |
2151690 |
72201542 |
Issue
Smith & Nephew, Inc. has initiated a field action to voluntarily remove seven (7) lots of BIORAPTOR™ Suture Anchors due to a potential for sterile barrier breach. Under certain shipping conditions, the distal end of the inserter can potentially pierce the packaging tray, compromising the sterile barrier.
Recall start date: October 29, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
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-76459
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