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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:176717

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 recall number

Z-0219-2020

Evidence summary

Product code
HSB
Recall status
Terminated
Event initiated
August 19, 2019
Root cause
Nonconforming Material/Component
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0219-2020

Field note

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