FDA-Device2019-11-06Class II
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.
OrthoPediatrics Corp
Hazard
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Sold states
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.
Affected count
969 total
Manufactured in
2850 Frontier Dr, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0219-2020Don't want to check this manually?
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