Device recall

Z-0696-2020: smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX…

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

Key facts

Recall number (Z-number) Z-0696-2020
Recall event 84325
Product smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
Product code GFJ
Recalling firm Smith & Nephew, Inc.
Recall class Class II
Status Terminated
Termination date May 7, 2021
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)