FDA recall Z-0219-2020

OrthoPediatrics Corp · Class II · device

Product

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

Reason for recall

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Distribution

Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.

Key facts

Status
Terminated
Initiation date
2019-08-19
Report date
2019-11-06
Termination date
2020-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0219-2020