Recall Z-1325-2023 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medtronic Sofamor Danek USA Inc
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T421
| Date | Apr 4, 2023 (initiated Feb 8, 2023) |
| Status | Open, Classified |
| Reason | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Root cause | Process control |
| Action | Medtronic Sofamor Danek notified customers of the recall on about 02/08/2023, via letter. Customers were instructed to identify and quarantine any affected products, return any affected products, complete and return the Customer Confirmation Form, and provide the letter to all personnel that should be aware or where affected products have been transferred/distributed. |
| Quantity | 2987 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechte |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051195 | GRAFTON DBM Osteotech, Inc., Dec 16, 2005 |