Recalls / —
—#105829
Product
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, 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: 0154947W and 0163314W
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 #105829. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.