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IVEA MODEL 500A (2017-10-11)
- Starting date:
- October 11, 2017
- Posting date:
- October 27, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-64954
Affected products
IVEA MODEL 500A
Reason
Rotational forces on the 16082 dowel pin during deploying or folding can cause the pin to slowly "screw" its way out of position. If the pin migrates enough to allow the brace to detach from the leg pivot fitting while a patient is ambulating with weight on the handles, the product could slump to one side. This may cause the patient to stumble.
Affected products
IVEA MODEL 500A
Lot or serial number
- 100325,
- 100463,
- 100476,
- 100478,
- 100482,
- 100486,
- 100487,
- 100491,
- 100556,
- 100569,
- 100570,
- 100571,
- 100572,
- 100574,
- 100592,
- 100598,
- 100600,
- 100602,
- 100605,
- 100615,
- 100620,
- 100626,
- 100627,
- 100640,
- 100641,
- 100642,
- 100643,
- 100645,
- 100646,
- 100647,
- 100650,
- 100677
Model or catalog number
500A
Companies
- Manufacturer
-
FIREFLY MEDICAL INC.,
320 EAST VINE DRIVE
FORT COLLINS
80524
Colorado
UNITED STATES