Z-1412-2013Class II

40 mm Rod, Item #BG1640

Name: Z-1412-2013 40 mm Rod, Item #BG1640
Creator: Spinal Solutions, LLC
Published: 2013-02-20
License: https://open.fda.gov/license/

Spinal Solutions, LLC / initiated 2013-02-20 / Terminated / root cause: labeling and UDI

FDA source

Spinal Solutions, LLC began a recall of 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has... on 2013-02-20. FDA classified it as Class II and gives the reason as "The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1412-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Posted: 2013-05-27
Terminated: 2014-03-26
Recalling firm: Spinal Solutions, LLC
Product: 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in commerce: 63 units
Distribution: USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Product codes and lots: Item #BG1640

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1412-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1409-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1410-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1411-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1412-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1413-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1414-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1415-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1416-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1417-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27
Z-1418-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-27

Product code MNI

K110633Class IILancer Pedicle Screw SystemSpinal Solutions, LLC / cleared 2011-12-15

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)