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Recall Observatory FDA recall evidence

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.

Z-0219-2020

August 19, 2019

Class II

Product summary

Firm
OrthoPediatrics Corp
Event
Event 83884
Status
Terminated
Classification
Class II
Quantity
969 total
Official record key
device-enforcement:Z-0219-2020

Official wording

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

Code information: 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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