Device recall

Z-2132-2026: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

FDA device recall · Class II · Orthorebirth Co Ltd

Key facts

Recall number (Z-number) Z-2132-2026
Recall event 98733
Product ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Product code MQV
Recalling firm Orthorebirth Co Ltd
Recall class Class II
Status Open, Classified
510(k) numbers K170620, K172573, K240453
FEI number 3011415547

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)