—#101815

Product

ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.

FDA product code: XLH
Affected lot / code info: **All lots.

Why it was recalled

Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic Sofamor Danek USA, Inc. sent "Voluntary Recall - Medtronic" letters on July, 2011 to all affected customers. The letter included; description of product and problem, and asked customers to stop using the product. Customers are asked to contact their Sales Representatives for replacement. For question on this recall call Medtronics Global Quality Department at (800) 876-3133.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.

Timeline

Recall initiated: 2011-07-06
Posted by FDA: 2011-08-10
Terminated: 2013-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.