Songer Spinal Cable System — Class II medical device recall Z-2053-2015
Terminated recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), reported 2015-07-15. The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Song
| Recall number | Z-2053-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-07-08 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2016-03-17 |
| Quantity | 25 |
| Reason classes | labeling, sterility |
| Lot numbers | 193368 |
| Expiration dates | 2019-09-09 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2053-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.