Z-1597-2015Class III

Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a...

Name: Z-1597-2015 Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a...
Creator: Spinal Elements, Inc
Published: 2015-04-09
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2015-04-09 / Terminated

FDA source

Spinal Elements, Inc began a recall of 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... on 2015-04-09. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1597-2015
Classification: Class III
Status: Terminated
Initiated: 2015-04-09
Posted: 2015-05-11
Terminated: 2015-06-25
Recalling firm: Spinal Elements, Inc
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
FDA root cause: Under Investigation by firm
Action: The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. Complete and return the enclosed "Customer Response Form." Any questions the firm states to contact the Customer Service department at 1.877.SPINAL5 Ext. 213.
Quantity in commerce: 588
Distribution: Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
Product codes and lots: Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1597-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1597-2015	Class III	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-11

Product code NKB

K071914Class IIMercury Spinal SystemSpinal Elements, Inc. / cleared 2007-10-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)