Spinal Elements 5.5 x 45MM Mercury lordosed rod. A recall
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…
Why was Spinal Elements 5.5 x 45MM Mercury lordosed rod. A 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013
- Product
- 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…
- Recalling firm
- Spinal Elements, Inc
- Quantity
- 588
- Distribution
- Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
- Recall date
- May 20, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)