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Wilson Frame Pad
- Starting date:
- March 31, 2017
- Posting date:
- May 16, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-63286
Reason
An audit of the manufacturing process has discovered a variance in the construction of the model 5319-37 pads that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame, which could lead to a pressure injury.
Affected products
Wilson Frame Pad
Lot or serial number
Not applicable
Model or catalog number
5319-37
Companies
- Manufacturer
-
Mizuho Orthopedic Systems, Inc.
30057 Ahern Avenue
Union City
94587-1234
California
UNITED STATES