Class 2 Device Recall Lumbar Matrix Scan (LMS)

• Date Initiated by Firm: January 29, 2010
• Date Posted: June 30, 2010
• Recall Status: Terminated on September 19, 2012
• Recall Number: Z-1935-2010
• Recall Event ID: 55796
• 510(K)Number: K990766
• Product Classification: Diagnostic Electromyograph - Product Code IKN
• Product: Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists of two devices. The first is a system of capital equipment referred to as CERSR Electromyography System, which includes a cart. The second device is disposable electrodes arrays, which are single use devices, used with the capital equipment that is adhered to the patient for monitoring the bioelectric signals produced by the muscles. The disposable is referred to as the Electrode Array. CERSR Electromyography System is packaged in a reusable crate maintained by SMI. The Electrode Array is packaged in a sealed foil pouch. Both devices are non-sterile and the packaging is for protection from damage during shipping.
• Code Information: Model Number(s): AM-0001-08-0 (CERSR) and 02003 (Electrode Array). CERSR serial numbers - 1,3, 6, 8, 9, 11, 12, 12a, 13, 14, 17, 19, 20, 21, and 23. Electrode Array lot numbers: 112607-01, 112007-01, 112807-01, 112907-01, 120407-01, 120607-01, 120707-01, 121007-01, 121107-01, 121207-01, 121307-01, 030508-01, 031108-01, 031208-01, 031308-01, 031408-01, 031708-01, 031808-01, 032608-01, 032708-01, 032808-01, 040308-01, 040408-01, 040708-01, 041008-01, 041108-01, 041409-01, 041609-01, 111008-01, 111208-01, 111708-01, 071309-01, 111308-01, 111808-01, 041309-01, 041409-01, 091009-01, & 111309-01.
• Recalling Firm/ Manufacturer: SpineMatrix Inc; 526 South Main St. Suite 311; Akron OH 44311
• For Additional Information Contact: 330-535-9530
• Manufacturer Reason for Recall: A full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design verification tests that either did not pass or did not meet the design input requirement. One requirement found that it was possible for the physician to think they were reviewing one patients scan, but were actually reviewing a scan from a different patient. This event did not happen; however,
• FDA Determined Cause: Device Design
• Action: On 1/29/2010 all customers were provided a Voluntary Product Recall Notification letter that was sent via U.S. Postal Service Certified Mail and they were contacted by phone to arrange for pick up of the devices. The letter identified the affected product and described the problem. Customers are to check their inventory for the affected product and contact SpineMatrix Customer Service to receive instruction as to how to return the affected product, if the firm did not already contact the customer. Customers must complete the verification form and return it. Questions should be directed to Customer Service.
• Quantity in Commerce: CERSR - 14 units, Electrode Arrays - 1,152 units
• Distribution: Nationwide Distribution -- CA, OH, OR & TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IKN and Original Applicant = PARASPINAL DIAGNOSTIC CORP.