Recall Z-2053-2015
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · initiated May 29, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-2053-2015
- Initiated
- May 29, 2015
- Posted by FDA
- July 9, 2015
- Terminated
- March 17, 2016
- Product code
- JDQ – Cerclage, Fixation
- Quantity
- 25
- Distribution
- Distributed in MA.
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI