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FLEXIBLE SHAFT, MEDULLARY (2016-05-19)
- Starting date:
- May 19, 2016
- Posting date:
- May 31, 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-58700
Affected products
A. FLEXIBLE SHAFT, MEDULLARY
Reason
Device did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
Affected products
A. FLEXIBLE SHAFT, MEDULLARY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
351.43
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES