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ORTHOPAEDIC WIRES (2015-12-29)
- Starting date:
- December 29, 2015
- Posting date:
- January 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56774
Affected Products
- ORTHOPAEDIC WIRES
Reason
The wire packages are correctly marked with a 'non-sterile' label, however, the enclosed instructions for use (IFU) states the devices are sterilized via gamma irradiation and should not be re-sterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided. Because the IFU does not provide information regarding sterilization, the hospital staff may be confused.
Affected products
A. ORTHOPAEDIC WIRES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 2704-3-018
- 6703-1-018
- 6704-1-018
- 6704-3-120
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
New Jersey
UNITED STATES