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KYPHX OSTEO INTRODUCER SYSTEM (2015-01-07)
- Starting date:
- January 7, 2015
- Posting date:
- April 2, 2015
- 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-52773
Recalled Products
KYPHX OSTEO INTRODUCER SYSTEM
Reason
Medtronic is performing a voluntary market removal of a single lot of Kyphon Express Osteo Introducer System diamond and bevel (CFN T34A lot WI14h054). The part and lot combination identified may contain either two bevel-tipped instruments or two diamond-tipped instruments, instead of one diamond tipped and one bevel tipped as indicated on the package label.
Affected products
KYPHX OSTEO INTRODUCER SYSTEM
Lot or serial number
WI14H054
Model or catalog number
T34A
Companies
- Manufacturer
-
Medtronic Sofamor Danek Usa Inc.
1800 Pyramid Place
Memphis
38132
UNITED STATES