Device recall

Z-1384-2023: EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella…

FDA device recall · Class II · Encore Medical, LP

Key facts

Recall number (Z-number) Z-1384-2023
Recall event 91906
Product EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Product code MBH
Recalling firm Encore Medical, LP
Recall class Class II
Status Open, Classified
510(k) numbers K212941
FEI number 1000116912

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)