Recall Z-1444-2012 ยท LXH Orthopedic Manual Surgical Instrument
Medtronic Sofamor Danek USA Inc
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
| Date | Apr 19, 2012 (initiated Mar 13, 2012) |
| Status | Terminated |
| Reason | Drill stops may be bypassed when the device is used with powered drilling instruments. |
| Root cause | Device Design |
| Action | 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 attach |
| Quantity | 247 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 Rica, Ecuador, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.