FDAClass IINovember 4, 2020

5.5MM Arthrogarde Hip Access Cannula recall

5.5MM Arthrogarde Hip Access Cannula

Why was 5.5MM Arthrogarde Hip Access Cannula recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
5.5MM Arthrogarde Hip Access Cannula
Recalling firm
Smith & Nephew, Inc.
Quantity
143 units
Distribution
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.
Recall date
November 4, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls