FDA-Device2014-12-03Class I
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).
Synthes (USA) Products LLC
Hazard
Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
Sold states
Distributed to MI, MT, and CO.
Affected count
24
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2015Don't want to check this manually?
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