CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report

Arthrogarde Hip Access Cannula recalled by Smith & Nephew

Smith & Nephew is recalling Arthrogarde Hip Access Cannula, distributed nationwide in the US. The recall was initiated on 21 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 72201743, Lot: 50838788, 50834909,50846565, 50842905 & 50822169.

Quantity recalled143 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0301-2021
FDA event ID: 86502
Recalling firm: Smith & Nephew, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Sep 2020
FDA classified: 27 Oct 2020
Reported: 4 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Sep 2020	Recall initiated by company
27 Oct 2020	Classified by FDA	+36 days
4 Nov 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

5.5MM Arthrogarde Hip Access Cannula

Where it was distributed

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.

Nationwide California Colorado Connecticut Delaware Georgia Iowa Illinois Indiana Maryland Missouri North Carolina New York Ohio Pennsylvania South Carolina Tennessee Texas Washington Wisconsin West Virginia

Questions about this recall

Is Arthrogarde Hip Access Cannula recalled?

Yes. Smith & Nephew recalled Arthrogarde Hip Access Cannula on 21 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0301-2021.

Why was it 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.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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