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A-642100 Fixed Offset Adapter (2013-10-25)
- Starting date:
- October 25, 2013
- Posting date:
- January 24, 2014
- 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-37537
Recalled products
- A-642100 Fixed Offset Adapter
Reason
Company has discovered that the A-642100 offset adapter can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely. Despite the fact that two incidents is not a high failure percentage, the failure mode at hand gives reason to act on the matter to prevent potential patient injury.
Affected products
A. A-642100 Fixed Offset Adapter
Lot or serial number
All lots
Model or catalog number
- A-642100
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND