—#100846

Product

ATLANTIS (R) Self-Tapping Variable Angle 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.

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042025
Affected lot / code info: Lot number H10A1268

Why it was recalled

Screws are longer then size etched on the screw.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-06-28
Posted by FDA: 2011-07-25
Terminated: 2012-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100846. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.