Agency classClass IIOur severity:High FDA (Devices)·Z-0635-2022·Announced 2022-02-16

Acufex Access Advanced Positioning Kit Recalled for Missing Sterilization

Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of unsterilized surgical instruments. While the hazard presents a clear risk of infection, no illnesses or injuries are reported in the source documentation. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scored as High (3).

Plain-English summary

Smith & Nephew, Inc. is recalling the Acufex Access Advanced Positioning Kit (Product Number 72205104). The recall was initiated because products were shipped to the Global Distribution Center instead of being sent for sterilization, and therefore did not undergo the required sterilization process.

The Acufex Access Advanced Positioning Kit is a surgical instrument indicated for use to position and distract the extremity during open and arthroscopic surgical procedures. Unsterilized instruments used in surgical procedures present a risk of infection to patients.

The recall affects 271 units. The affected lot numbers are 50971615, 50971617, and 50967788. Distribution was worldwide, with U.S. distribution in the states of Colorado, Connecticut, Florida, Massachusetts, Maryland, Oregon, Pennsylvania, and Wisconsin, as well as Canada.

The recalled product

Product: 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
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Surgical Equipment
Hazard: sterilization-failure
infection-risk
Affected units: 271

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 (2)

Lot Numbers: 50971615
50971617 & 50967788

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Smith & Nephew, Inc.

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