—#158158

Product

Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K131425
Affected lot / code info: P/N 9734724, 9734724K

Why it was recalled

Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.

Root cause (FDA determination)

Device Design

Action the firm took

Medtronic sent an Urgent Medical Device Correction letter dated June 27, 2017, to all affected consignees. The letter notifies consignees of the product correction and requests that practitioners follow the attached use instructions for devices. Practitioners are to identify product damage before each procedure by opening and closing the device jaw with the T-handle. It is instructed that practitioners not continue turning the screw if resistance is met, as this may break the washer. Clamps are not to be used if the jaws remain closed when attempting to open a clamp or if the clamp screw back is out of the clamp. It is asked that this check is done to all inventory and any damaged product is to be reported to Medtronic at 1-800-595-9709 and quarantined. Revised product is available. Consignees are asked to complete and return the provided Consignee Response Form by email to the firm at RS.NavFCA@medtronic.com or by fax to 651-367-7075. Any questions can be directed to 1-800-595-9709.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania, Australia, Bangladesh, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Kenya, Latvia, Luxembourg, Malaysia, Martinique, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, & Vietnam.

Timeline

Recall initiated: 2017-06-29
Terminated: 2023-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158158. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.