Device 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.
Z-1215-2019
Product summary
- Event
- Event 82562
- Status
- Terminated
- Classification
- Class II
- Quantity
- 355
- Official record key
device-enforcement:Z-1215-2019
Official wording
Reason: During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Code information: Serial/Lot Number 18247037
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
breach in sterility