Device product
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Z-1266-2013
Product summary
- Event
- Event 53487
- Status
- Terminated
- Classification
- Class III
- Quantity
- 68 units total
- Official record key
device-enforcement:Z-1266-2013
Official wording
Reason: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Code information: Lot Number: 080602
Distribution pattern: Distributed in OH and PA.
Derived failure modes
-
Unknown
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.