Recall Z-2876-2011
Medtronic Sofamor Danek USA Inc · initiated June 28, 2011
Product
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.
Codes / lots: Lot number H09M9774
Reason for recall
Screws are longer then size etched on the screw.
FDA-determined cause: Other
Action taken
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 concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
Details
- Recall number
- Z-2876-2011
- Initiated
- June 28, 2011
- Posted by FDA
- July 25, 2011
- Terminated
- December 24, 2012
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- 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.
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2874-2011 | CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor…Screws are longer then size etched on the screw. | 06/28/2011Terminated |
| Z-2875-2011 | CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor…Screws are longer then size etched on the screw. | 06/28/2011Terminated |
| Z-2877-2011 | VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800…Screws are longer then size etched on the screw. | 06/28/2011Terminated |
| Z-2878-2011 | ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA…Screws are longer then size etched on the screw. | 06/28/2011Terminated |