Device 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.
Z-2053-2015
Product summary
- Event
- Event 71474
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2053-2015
Official wording
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.
Code information: Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
Distribution pattern: Distributed in MA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled