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

Recalled May 1, 2019 · FDA recall Z-1215-2019 · Stryker Instruments Div. of Stryker

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. · FDA Class II

Units

355

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Stryker Instruments Div. of Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →