—#105828

Product

CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation

FDA product code: KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042025
Affected lot / code info: Lot Numbers: 0132008W, 0150703W, 0150705W, and 0166823W

Why it was recalled

One screw may be longer then size etched on the screw.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.

Timeline

Recall initiated: 2011-11-30
Posted by FDA: 2012-01-11
Terminated: 2012-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.