FDA Recall
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.
Recall: Z-2053-2015
·
Initiated May 29, 2015
Recall
- Recall Number
- Z-2053-2015
- Event Number
- 71474
- Firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- FEI Number
- 1000115331
- Product Code
- JDQ
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- May 29, 2015
- Posted
- July 9, 2015
- Terminated
- March 17, 2016
- Address
- 375 River Park Cir, Marquette, MI, 49855-1781
Description
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.
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.
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.
Distribution
Distributed in MA.
Quantity
25