Stryker Instruments Div. of Stryker Corporation recalls Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades ar…

Recall date

March 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1215-2019

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

US Nationwide in the states of: FL, GA, ID, KY, MA, MD, MN, NC, PA, UT, WA, and WI. The products were distributed to the following foreign countries: Canada, France, Italy, Netherlands.

Why it was recalled

During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.