Reported Jul 15, 2015 · Terminated
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
- 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.
- Lot codes and dates
- Lot NumberPL 193368
- Manufacture Date09/09/2014
- Expiration Date09/09/2019
- Amount recalled
- 25
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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