Health product recall

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

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

Performance Series Sagittal Blade

Lot or serial number

18247037

Model or catalog number

6125-127-100

Companies
Manufacturer

Stryker Instruments

4100 East Milham Ave

Kalamazoo

49001

Michigan

UNITED STATES