Device product
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).
Z-0226-2015
Product summary
- Event
- Event 69603
- Status
- Terminated
- Classification
- Class I
- Quantity
- 24
- Official record key
device-enforcement:Z-0226-2015
Official wording
Reason: 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.
Code information: Part Number 04.634.002 Lot Number 6816781
Distribution pattern: Distributed to MI, MT, and CO.
Derived failure modes
-
Unknown
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.