FDA Medical Device Recalls (openFDA)
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): 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 number
- Z-2053-2015
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- 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.
- Status
- Terminated
- Initiated
- 2015-05-29
- Posted
- 2015-07-09
- Terminated
- 2016-03-17
- 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.
- Root cause
- Labeling Change Control
- 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.
- Quantity
- 25
- Distribution
- Distributed in MA.
- Lot, serial or model codes
- Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDQ
- Firm FEI
- 1000115331
- Firm city
- Marquette
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28