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Low Profile Rotate with EVO (prosthetic device) (2015-03-04)
- Starting date:
- March 4, 2015
- Posting date:
- April 27, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53101
Recalled Products
A. Low Profile Rotate with EVO (prosthetic device)
Reason
The threads of the outer tube of the shock module of low profile rotate are short, which results in insecure assembly. Use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.
Affected products
A. Low Profile Rotate with EVO (prosthetic device)
Lot or serial number
141022
Model or catalog number
- LRF062
- LRFU062
- LRP062
- LRPU062
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND