Recall Z-0977-2014 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medtronic Sofamor Danek USA Inc
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
| Date | Feb 12, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm. |
| Root cause | Packaging process control |
| Action | The firm, Medtronic, sent an "URGENT-V voluntary Market Removal (Recall)" communication letter and questionnaire packet (via FedEx) dated January 3, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the product from normal storage locations; Do not use the product; and as applicable, contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product or call our Global Quality Department at 800-876-3133 ext 3197. In addition, the customers were instructed to disseminate this i |
| Quantity | 30 units |
| Distribution | US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ. |
| FDA record | Open on fda.gov |