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Terminated

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.

FDA Recall Z-2053-2015 · Posted 2015-07-09

Recalling FirmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Recall StatusTerminated
Product CodeJDQ
Date Initiated2015-05-29
Date Terminated2016-03-17
Product Quantity25

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.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in MA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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