Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306
FDA device recall Z-1331-2023 · posted 2023-04-04 · Open, Classified
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MBP
- Quantity affected
- 10037 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, Hon
- Date initiated
- 2023-02-08
- Date posted
- 2023-04-04
- Location
- Memphis, TN
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