CLASS II ONGOING Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

Acufex Access Advanced Positioning Kit - indicated recalled

Smith & Nephew is recalling Acufex Access Advanced Positioning Kit - indicated for use to position and distract the, distributed nationwide in the US. The recall was initiated on 14 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 50971615, 50971617 & 50967788

Quantity recalled271 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-0635-2022
FDA event ID: 89443
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 14 Dec 2021
FDA classified: 10 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Surgical Instruments

Timeline

14 Dec 2021	Recall initiated by company
10 Feb 2022	Classified by FDA	+58 days
16 Feb 2022	Published in enforcement report	+6 days

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

Reason for recall

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.

Nationwide Colorado Connecticut Florida Massachusetts Maryland Oregon Pennsylvania Wisconsin

Questions about this recall

Why was it recalled?

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

Which lots are affected?

Lot Numbers: 50971615, 50971617 & 50967788

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.

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 26 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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