Stryker Performance Series Sagittal Blade Recall for Sterility Breach
Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach in sterility for a medical device used in surgery, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 355 units of the Performance Series Sagittal Blade, Catalog Number 6125-127-100. These medical devices are used by surgeons in fully equipped operating rooms for cutting and shaping bone in orthopedic procedures, including total-knee, hip, and shoulder surgeries.
The recall was initiated because packaging materials for a small portion of the lot may not have been properly positioned during manufacture. This defect resulted in a potential breach in sterility for the affected devices.
The products were distributed nationwide in the United States to Florida, Georgia, Idaho, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, Pennsylvania, Utah, Washington, and Wisconsin. They were also distributed to Canada, France, Italy, and the Netherlands. The affected units are identified by Serial/Lot Number 18247037.
The recalled product
- 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 355
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial/Lot Number 18247037
Distribution
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