Z-0301-2021 Class II Terminated
FDA device recall Z-0301-2021 was initiated by Smith & Nephew, Inc. on September 21, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated March 22, 2024). Affected quantity: 143 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 21, 2020
- Termination Date
- March 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 143 units
Product Description
5.5MM Arthrogarde Hip Access Cannula
Reason for Recall
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.
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.
Code Information
Model: 72201743, Lot: 50838788, 50834909,50846565, 50842905 & 50822169.