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STRYKER AUTOPLEX SYSTEM WITHOUT NEEDLES AND CEMENT (2016-06-13)
- Starting date:
- June 13, 2016
- Posting date:
- July 19, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-59386
Affected products
A. STRYKER AUTOPLEX SYSTEM WITHOUT NEEDLES AND CEMENT
Reason
The AutoPlex System is used for mixing bone cement and delivering bone cement percutaneously. The valve on the AutoPlex System's injection assembly may become blocked, resulting in a cement backflow towards the injector handle.
Affected products
A. STRYKER AUTOPLEX SYSTEM WITHOUT NEEDLES AND CEMENT
Lot or serial number
- "16040012
- 16057012
- 16078012
- 16104012
- 16112012"
Model or catalog number
- 0605-887-000
Companies
- Manufacturer
-
Stryker Instruments
4100 East Milham Ave
Kalamazoo
Michigan
UNITED STATES