Performance Series Sagittal Blade (2019-03-18)

Starting date:

March 18, 2019

Posting date:

March 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69434

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  Reason
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  Affected products

Affected Products

Performance Series Sagittal Blade

Reason

A total of three (3) complaints were found over the past 5 years (20-Feb-2014 to 20-Feb-2019). The complaint devices were found upon incoming inspection and were not used during a surgical procedure. During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.

Affected products