Device recall

Z-0125-2020: OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing…

FDA device recall · Class II · OrthoPediatrics Corp

Key facts

Recall number (Z-number) Z-0125-2020
Recall event 83767
Product OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
Product code HSB
Recalling firm OrthoPediatrics Corp
Recall class Class II
Status Terminated
Termination date Oct 26, 2020
510(k) numbers K172583
FEI number 3006460162

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

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