ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF 876-460, QTY: 1 EA, Rx only, Medtronic Sofamore D

FDA device recall Z-1442-2012 · posted 2012-04-19 · Terminated

Recall details

Recalling firm

Medtronic Sofamor Danek USA Inc

Reason for recall

Drill stops may be bypassed when the device is used with powered drilling instruments.

Action taken

Medtronic notified their US Sales force on March 5, 2012, of the upcoming field action. The written "Voluntary Recall" communications were disseminated March 13 and March 14 to the US consignees. The letter identified the affected products, problem and actions to be taken. Customers are instructed to 1) disseminate this information to personnel within their facility as appropriate; 2) review work area, district sales office, and sample inventory for affected product; 3) complete the attached Risk Manager Questionnaire and return any recalled product; and 4) Sign and acknowledge the attached Sales Rep Questionnaire indicating receipt of this letter. For questions or concerns, contact your Medtronic Sales Representative or Global Quality Department at 800-876-3133, extension 3197.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

2540 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa

Date initiated

2012-03-13

Date posted

2012-04-19

Date terminated

2013-04-30

Location

Memphis, TN