Z-1257-2013Class III

Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization...

Name: Z-1257-2013 Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization...
Creator: Spinal Elements, Inc
Published: 2009-04-17
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2009-04-17 / Terminated / root cause: manufacturing process

FDA source

Spinal Elements, Inc began a recall of Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally... on 2009-04-17. FDA classified it as Class III and gives the reason as "Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1257-2013
Classification: Class III
Status: Terminated
Initiated: 2009-04-17
Posted: 2013-05-07
Terminated: 2013-05-07
Recalling firm: Spinal Elements, Inc
Product: Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.
Quantity in commerce: 68 units total
Distribution: Distributed in OH and PA.
Product codes and lots: Lot Number: 080593

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1246-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1247-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1248-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1249-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1250-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1251-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1252-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1253-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1254-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1255-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1256-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1257-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1258-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1259-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1260-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1261-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1262-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1263-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1264-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1265-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1266-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07

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)