FDA Device recall Z-2053-2015
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile
- FDA Device
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile by Rti Surgical Dba Pioneer Surgical Technology, citing 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, St….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2053-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Rti Surgical Dba Pioneer Surgical Technology |
| Distribution | MA |
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.
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.
Identifiers
| code_info | Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2053-2015%22
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