Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T60020
FDA device recall Z-1334-2023 · 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
- 4348 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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