Cannulated Screw System
Brand(s)
Last updated
Summary
Product
Cannulated Screw System
Issue
Medical devices - Performance issue
Medical devices - Unauthorised device
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Cannulated Screw System | More than 10 numbers, contact manufacturer. | 00-1402-6066 00-1402-6072 00-1402-6090 |
| Cannulated Screw System | More than 10 numbers, contact manufacturer. | 00-1402-6066 00-1402-6072 00-1402-6090 |
Issue
The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252.
Recall start date: March 1, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
Orthopediatrics Corporation
2850 Frontier Drive, Warsaw, Indiana, United States, 46582
Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Identification number
RA-73327
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