CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
Songer Spinal Cable System, Single Cable, Crimp, Bar recalled
RTI Surgical, Inc. ( is recalling Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed in Massachusetts. The recall was initiated on 29 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2053-2015
- FDA event ID
- 71474
- Recalling firm
- RTI Surgical, Inc. (, Marquette, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2015
- FDA classified
- 8 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Spinal Implants
Timeline
| 29 May 2015 | Recall initiated by company | |
| 8 Jul 2015 | Classified by FDA | +40 days |
| 15 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Distributed in MA.
Questions about this recall
Is Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile recalled?
Yes. RTI Surgical, Inc. ( recalled Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile on 29 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2053-2015.
Why was it recalled?
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.
Which lots are affected?
Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
Where was it sold?
Distributed in MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RTI Surgical, Inc. (
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|---|---|---|---|---|---|
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
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Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |