Device product
5.5MM Arthrogarde Hip Access Cannula
Z-0301-2021
Product summary
- Event
- Event 86502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 143 units
- Official record key
device-enforcement:Z-0301-2021
Official wording
Reason: The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
Code information: Model: 72201743, Lot: 50838788, 50834909,50846565, 50842905 & 50822169.
Distribution pattern: Domestic Distribution: CA, CO, CT, GA, IA, IL, IN, MD, MO, NC, NY, OH, PA, SC, TN, TX, WA, WI, WV. International Distribution: AU, BR, CA, CL, CN, CO, DE, ES, GB, HK, KR, PA, PT, TW.
Derived failure modes
-
Unknown
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.