Recall Z-1330-2023 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medtronic Sofamor Danek USA Inc
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product
| 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 | 47436 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
This recall record lists no 510(k) number.