Synthes (USA) Products LLC: Medical Device Recall in 2014 - (Recall #: Z-0226-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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).

Product Classification:

Class I

Date Initiated: October 23, 2014

Date Posted: December 3, 2014

Recall Number: Z-0226-2015

Event ID: 69603

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.

Status: Terminated

Product Quantity: 24

Code Information:

Part Number 04.634.002 Lot Number 6816781

Distribution Pattern:

Distributed to MI, MT, and CO.

Voluntary or Mandated:

Voluntary: Firm initiated