Stryker Shaver Handpiece Sterilization Tray Recalled for Validation Deficiencies
Stryker Endoscopy is recalling 1,992 Shaver Handpiece Sterilization Trays because the provided STERRAD 100S sterilization parameters did not fully consider all worst-case scenarios during validation testing.
What this means for you
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 medical device where the sterilization validation process was deficient, creating a risk of harm (inadequate sterilization) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Endoscopy is recalling 1,992 Shaver Handpiece Sterilization Trays (Model number 272-700-000). These trays are used for the sterilization of Stryker Endoscopy arthroscopic shavers. The affected units were distributed worldwide.
The recall was initiated because the STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing. This deficiency may affect the reliability of the sterilization process for the associated shaver handpieces.
Healthcare facilities and users should stop using the affected trays and contact Stryker Endoscopy for further instructions. The specific lot numbers affected are listed in the agency's recall record Z-1872-2014.
The recalled product
- Product
- Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
- Manufacturer
- Stryker Endoscopy
- Affected units
- 1,992
Distribution
Distribution scope not specified by the agency.
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