Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
Reported: April 12, 2023 Initiated: February 8, 2023 #Z-1331-2023
Product Description
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
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.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units 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, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 10037 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2023. Severity: Moderate. Recall number: Z-1331-2023.
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