ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Dan

FDA device recall Z-2985-2011 · posted 2011-08-10 · Terminated

Recall details

Recalling firm

Medtronic Sofamor Danek USA Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

XLH

Quantity affected

191 units

Distribution

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,

Date initiated

2011-07-06

Date posted

2011-08-10

Date terminated

2013-04-26

Location

Memphis, TN