PlainRecalls
FDA Devices Critical Class I Terminated

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).

Reported: December 3, 2014 Initiated: October 23, 2014 #Z-0226-2015

Product Description

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).

Reason for Recall

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.

Details

Units Affected
24
Distribution
Distributed to MI, MT, and CO.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by Synthes (USA) Products LLC. Units affected: 24.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Critical. Recall number: Z-0226-2015.

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