Z-1215-2019 Class II Terminated
FDA device recall Z-1215-2019 was initiated by Stryker Instruments Div. Of Stryker Corporation on Mar 19, 2019 and is designated Class II. Reason for recall: During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. The recall status is terminated (terminated Jun 26, 2020). Affected quantity: 355.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- Mar 19, 2019
- Termination Date
- Jun 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 355
Product Description
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.
Reason for Recall
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
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.
Code Information
Serial/Lot Number 18247037
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1215-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026