The Recall Desk
HighFDA (Devices)·Z-0301-2021·Announced 2020-11-04

Smith & Nephew Recalls 5.5MM Arthrogarde Hip Access Cannula

Smith & Nephew is recalling 143 units of 5.5MM Arthrogarde Hip Access Cannulas because the J Lock feature was manufactured incorrectly, preventing proper locking into irrigation extenders or arthroscopes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect presents a risk of harm (improper locking) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 143 units of the 5.5MM Arthrogarde Hip Access Cannula. The recall involves specific model and lot numbers: Model 72201743, Lots 50838788, 50834909, 50846565, 50842905, and 50822169.

The recall was initiated because the J Lock feature on the cannula body was manufactured incorrectly. This defect prevents the cannula from locking into an irrigation extender or arthroscope in the correct orientation.

The affected products were distributed domestically in California, Colorado, Connecticut, Georgia, Iowa, Illinois, Indiana, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin, and West Virginia. International distribution included Australia, Brazil, Canada, Chile, China, Colombia, Germany, Spain, Great Britain, Hong Kong, South Korea, Panama, Portugal, and Taiwan. Healthcare providers and facilities should stop using the affected units and contact Smith & Nephew for further instructions.

The recalled product

Product
5.5MM Arthrogarde Hip Access Cannula
Affected units
143

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Model: 72201743
  • Lot: 50838788
  • 50834909
  • 50846565
  • 50842905 & 50822169.

Distribution