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Contender Post-Op Knee Brace (2015-12-07)
- Starting date:
- December 7, 2015
- Posting date:
- January 22, 2016
- 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-56770
Affected Products
- Contender Post-Op Knee Brace
Reason
Corflex received notification from a material supplier that a component used to manufacture the brace was out of specification. The hardness of the drop lock teeth could be insufficient, causing this feature to fail under stress. In circumstances where a sudden and/or higher than normal force is exerted against an engaged drop lock, the brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, posing a safety risk to the patient.
Affected products
A. Contender Post-Op Knee Brace
Lot or serial number
all lots
Model or catalog number
- 75-7500-000
- 75-7500-011
- 75-7500-038
- 75-7500-075
- 75-7500-087
- 75-7500-231
- 75-7550-000
Companies
- Manufacturer
-
Corflex
669 E. INDUSTRIAL PARK DRIVE
MANCHESTER
03109
New Hampshire
UNITED STATES