FDAFDA · Food and drugs·Recall number Z-0301-2021
5.5MM Arthrogarde Hip Access Cannula
Published November 4, 2020 · Recall initiated: September 21, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- 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.
- Lot
- Model: 72201743, Lot: 50838788, 50834909,50846565, 50842905 & 50822169.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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