Recall Z-1414-2013— Spinal Solutions, LLC

Name: FDA recall Z-1414-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-20

Class II · Terminated

Class II FDA medical device recall by Spinal Solutions, LLC, initiated 2013-02-20, terminated 2014-03-26. It names one FDA 510(k) clearance: K110633. Product: 60 mm Rod, Item #BG1660 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.. Reason: 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..

Recalling firm: Spinal Solutions, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Terminated: 2014-03-26
Firm location: Murrieta, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110633 — LANCER PEDICLE SCREW SYSTEMSpinal Solutions, LLC·cleared 2011-12-15

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

60 mm Rod, Item #BG1660 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.

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.

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