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 2151422 | 72203281 72203280 |
| Bioraptor 2.3 Pk Suture Anchor W/Ultrabraid Suture | 2151690 2151242 2146369 2151691 2153489 | 72201542 72201541 |
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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