OrthoPediatrics Corp recalls Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: a

Recalled November 6, 2019 · FDA recall Z-0219-2020 · OrthoPediatrics

Hazard

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

Units

969 total

Sold at

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.

Description

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

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.

Manufacturer(s)

OrthoPediatrics Corp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →