Device recall

Z-0770-2023: Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm…

FDA device recall · Class II · Acumed LLC

Key facts

Recall number (Z-number) Z-0770-2023
Recall event 90996
Product Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S…
Product code HWC
Recalling firm Acumed LLC
Recall class Class II
Status Open, Classified
510(k) numbers K221333
FEI number 1000125930

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)