Recall Z-2876-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Medtronic Sofamor Danek USA Inc
CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
| Date | Jul 25, 2011 (initiated Jun 28, 2011) |
| Status | Terminated |
| Reason | Screws are longer then size etched on the screw. |
| Root cause | Other |
| Action | Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or con |
| Quantity | 29 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Netherlands, Brazil, Columbia, Hong Kong, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091974 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc., Sep 2, 2009 |