—#108140

Product

VERTEX MAX (R) Cannulated, VERTEX MAX (R), and VERTEX (R) Reconstruction System Adjustable Drill Stop, REF 6860460, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 Product Usage: Manual orthopedic adjustable drill stop

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 61624, 61670, SK10341, SK10777, SK07G002

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

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 Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.

Timeline

Recall initiated: 2012-03-13
Posted by FDA: 2012-04-19
Terminated: 2013-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108140. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.