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.
- Recall Initiated
- May 29, 2015
- Posted
- July 9, 2015
- Terminated
- March 17, 2016
- Recall Number
- Z-2053-2015
- Quantity
- 25
- Firm Location
- Marquette, MI
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.
Distribution
Distributed in MA.
Lot / Code Info
Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
Root Cause
Labeling Change Control
Action Taken
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.
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