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Shaver Handpiece Sterilization Tray (2014-05-30)
- Starting date:
- May 30, 2014
- Posting date:
- July 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40217
Recalled Products
Shaver Handpiece Sterilization Tray
Reason
During testing shaver hand piece tray failed Sterrad 100s half cycle testing and did not demonstrate a sterility assurance level of 10-6 for the TPS shaver. It has been determined that the reprocessing guide (P10299 Rev. A) is the non-conforming part of the shaver hand piece tray and the sterilization method with inadequate sterilization validation (Sterrad 100s) needs to be removed as a sterilization option for the TPS small joint shaver.
Affected products
Shaver Handpiece Sterilization Tray
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
0272-700-000
Companies
- Manufacturer
-
Stryker Endoscopy
5900 Optical Court
San Jose
95138
California
UNITED STATES