PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 23, 2019 Initiated: August 19, 2019 #Z-0125-2020

Product Description

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

Details

Recalling Firm
OrthoPediatrics Corp
Units Affected
211 units
Distribution
Nationwide Foreign: Australia
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by OrthoPediatrics Corp. Units affected: 211 units.
Why was this product recalled?
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Which agency issued this recall?
This recall was issued by the FDA Devices on October 23, 2019. Severity: Moderate. Recall number: Z-0125-2020.