ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.
FDA Recall Z-2985-2011 · Posted 2011-08-10
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Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeXLH
Date Initiated2011-07-06
Date Terminated2013-04-26
Product Quantity191 units
Reason for Recall
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.
Firm Action
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.
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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