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Full Radius Blade
- Starting date:
- January 28, 2017
- Posting date:
- February 27, 2017
- 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-62378
Reason
Smith & Nephew is initiating a voluntary field corrective action/recall of various batches of the full radius blade, 3.5mm due to a manufacturing error. The product was manufactured with a black ULTEM sluff chamber instead of a blue polycarbonate one. Smith & Nephew Considers that the use or exposure to the product is unlikely to cause adverse health consequences. The colour of the sluff chamber is irrelevant to the clinical use and the material has no impact on the device performance. The device will perform as intended.
Affected products
Full Radius Blade
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7205305
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES