# FDA recall Z-1215-2019

> **Stryker Instruments Div. of Stryker Corporation** · Class II · device recall initiated 2019-03-19.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-1215-2019
- **Recalling firm:** Stryker Instruments Div. of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-19
- **Report date:** 2019-05-01
- **Termination date:** 2020-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2019

## Citation

> AI Analytics. FDA recall Z-1215-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1215-2019. Source: US FDA. Licensed CC0.

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