Various SPR Disposable Products (2017-11-21)

Starting date:

November 21, 2017

Posting date:

November 24, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-65232

• Reason
• Affected products

Affected products

A. INTRAMEDULLARY BRUSHES - DISPOSABLE
B. ADVANCED CEMENT MIXING BOWL, EMPTY CEMENT CARTRIDGE, NOZZLE AND PRESSURIZER
C. STRYKER AUTOPLEX SYSTEM WITHOUT NEEDLES AND CEMENT
D. PROX PRESS

Reason

During routine bioburden testing [November 10th to 20th 2017], Stryker found that the levels of bioburden were higher than our internal acceptable rates. Therefore, Stryker is initiating this voluntary recall, as the sterility of the product cannot be confirmed.

Affected products