Recalls / —
—#127531
Product
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
- FDA product code
- HRX — Arthroscope
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K941333
- Affected lot / code info
- Part Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329.
Why it was recalled
STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Device Correction letters were sent on May 23, 2014 to all users by certified mail. Internation sites will receive notification and be responsible for contacting customers.
Recalling firm
- Firm
- Stryker Endoscopy
- Address
- 5900 Optical Ct, San Jose, California 95138-1400
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2014-05-19
- Posted by FDA
- 2014-06-25
- Terminated
- 2015-05-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #127531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.