FDA-Device2020-11-04Class II
5.5MM Arthrogarde Hip Access Cannula
Smith & Nephew, Inc.
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.
Sold states
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.
Affected count
143 units
Manufactured in
150 Minuteman Rd, N/A, Andover, MA, United States
Products
5.5MM Arthrogarde Hip Access Cannula
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2021Don't want to check this manually?
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