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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:131023

Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).

Official recall number

Z-0226-2015

Evidence summary

Product code
NKB
Recall status
Terminated
Event initiated
October 23, 2014
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0226-2015

Field note

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