Z-2053-2015Class II

Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System...

Name: Z-2053-2015 Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System...
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2015-05-29
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2015-05-29 / Terminated / root cause: labeling and UDI

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has... on 2015-05-29. FDA classified it as Class II and gives the reason as "The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2053-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-07-09
Terminated: 2016-03-17
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
Product code: JDQ Cerclage, Fixation
Reason for recall: The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 5/29/15, RTI Surgical sent DePuy/Synthes Spine Inc. with an URGENT: Medical Device Voluntary Recall Notification identifying the recalled product, reason for recall, potential risks, and immediate actions required.
Quantity in commerce: 25
Distribution: Distributed in MA.
Product codes and lots: Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2053-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2053-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08

Product code JDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)