Reported May 20, 2015 · Terminated
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of…
Spinal Elements, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Spinal Elements, Inc · 3115 Melrose Dr Suite 200 · Carlsbad, CA · 92010-6690
Is this the product you have?
- Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
- Lot codes and dates
- Part Number60100-045
- Lot Numbers
140086140449141013
- Amount recalled
- 588
Where it was sold
Why it was recalled
Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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