FDA-Device2019-05-01Class II
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 surgeo
Stryker Instruments Div. of Stryker Corporation
Hazard
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Sold states
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.
Affected count
355
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2019Don't want to check this manually?
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