FDA recall Z-0125-2020

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

Reason for recall

Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

Distribution

Nationwide Foreign: Australia

Key facts

Status

Terminated

Initiation date

2019-08-19

Report date

2019-10-23

Termination date

2020-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2020