Z-1545-2012

Instructions For Use: "SmartLOXInstructions for Use Cervical Plate SystemSTERILIZATIONThe...

Name: Z-1545-2012 Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The...
Creator: Captiva Spine, Inc
Published: 2012-03-22
License: https://open.fda.gov/license/

CAPTIVA SPINE, Inc. / initiated 2012-03-22 / Terminated / root cause: labeling and UDI

FDA source

Captiva Spine, Inc began a recall of Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied... on 2012-03-22. The reason FDA records is "Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated". 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-1545-2012
Status: Terminated
Initiated: 2012-03-22
Posted: 2012-05-14
Terminated: 2013-11-18
Recalling firm: CAPTIVA SPINE, Inc.
Product: Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter, FL 33477. Tel: 877-772-5571***CAPTIVA SPINE***". Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Captiva Spine sent a "VOLUNTARY CORRECTION NOTIFICATION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides steps for the correction and a verification form for customers to complete. Customers should contact the firm at 877-772-5571 for questions concerning this notice.
Quantity in commerce: 14 units
Distribution: Nationwide Distribution including the states of FL, IN, UT, GA, PA, TX, AL, NC, MI, and MN.
Product codes and lots: Serial Number: 002, 004, 007, 009, 011, 015, 017, 018, 019, 020, 024, 025, 035 and 030.

Product code KWQ

K073708Class IIFixed, Variable & Corpectomy Cervical Plate SystemPrecision Surgery , Ltd. / cleared 2008-06-03

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)