Recall Z-2053-2015— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class II · Terminated
Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2015-05-29, terminated 2016-03-17. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-29
- Terminated
- 2016-03-17
- Firm location
- Marquette, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.