Device recall

Z-0635-2022: Acufex Access Advanced Positioning Kit - indicated for use to position and…

FDA device recall · Class II · Smith & Nephew, Inc.

Key facts

Recall number (Z-number) Z-0635-2022
Recall event 89443
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
Product code KQZ
Recalling firm Smith & Nephew, Inc.
Recall class Class II
Status Open, Classified
FEI number 1020279

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)