Recall Z-1597-2015— Spinal Elements, Inc

Name: FDA recall Z-1597-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-09

Class III · Terminated

Class III FDA medical device recall by Spinal Elements, Inc, initiated 2015-04-09, terminated 2015-06-25. It names one FDA 510(k) clearance: K071914. 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, 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.. Reason: 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..

Recalling firm: Spinal Elements, Inc
Classification: Class III
Status: Terminated
Initiated: 2015-04-09
Terminated: 2015-06-25
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071914 — MERCURY SPINAL SYSTEMSpinal Elements, Inc.·cleared 2007-10-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.