Z-0226-2015Class I

Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction...

Name: Z-0226-2015 Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction...
Creator: Synthes (USA) Products LLC
Published: 2014-10-23
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2014-10-23 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System... on 2014-10-23. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0226-2015
Classification: Class I
Status: Terminated
Initiated: 2014-10-23
Posted: 2014-11-26
Terminated: 2015-08-10
Recalling firm: Synthes (USA) Products LLC
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).
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated October 23, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check inventory and remove affected stock, call Synthes to obtain a Return Authorization for the device, and to return the completed verification section of the response form by fax to (610) 430-7083 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450.
Quantity in commerce: 24
Distribution: Distributed to MI, MT, and CO.
Product codes and lots: Part Number 04.634.002 Lot Number 6816781

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0226-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0226-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code NKB

K100952Class IIModification to Synthes Matrix SystemSynthes Spine / cleared 2010-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)