Recall Z-2053-2015 ยท JDQ Cerclage, Fixation
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.
| Date | Jul 9, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.