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Recall Observatory FDA recall evidence

Device product

5.5MM Arthrogarde Hip Access Cannula

Z-0301-2021

September 21, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
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

    reason.no_named_rule · v1.0.0

    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.