Spinal Solutions, LLC: Medical Device Recall in 2013 - (Recall #: Z-1416-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg 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 Classification:

Class II

Date Initiated: February 20, 2013

Date Posted: June 5, 2013

Recall Number: Z-1416-2013

Event ID: 64586

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.

Status: Terminated

Product Quantity: 35 units

Code Information:

Item # 21411-706 21411-707 21411-708 21411-709 21411-710 21411-711 21411-712

Distribution Pattern:

USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated