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Recall Observatory FDA recall evidence

Device 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.

Z-2053-2015

May 29, 2015

Class II

Product summary

Firm
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Event
Event 71474
Status
Terminated
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-2053-2015

Official wording

Reason: 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.

Code information: Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019

Distribution pattern: Distributed in MA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled