24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 Screws
Brand(s)
Last updated
Summary
Product
24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 Screws
Issue
Medical devices - Performance
What to do
Customer notification. Customers to return affected devices to manufacturer for replacement.
Affected products
| Affected product | Lot or serial number | Model or catalog number |
|---|---|---|
| 24.0mm Acutrak 2 – 4.7 Screw | 619496 | 30-0624 |
| 35.0mm Acutrak 2 – 4.7 Screw | 640388 | 30-0635 |
| 45.0mm Acutrak 2 – 4.7 Screw | 620722 | 30-0645 |
Issue
Three different sizes of Acumed's Acutrak 2 system screws were identified to have Acutrack 2 screw the cutting flute of the screw not straight at the tip. To date there have been no complaint incidents or adverse events reported related to the devices.
Recall start date: December 27, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
Acumed, LLC
5885 Ne Cornelius Pass Road, Hillsboro, Oregon, United States, 97124
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-76880
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