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Medtronic Sofamor Danek USA Inc recalls Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T
Recalled April 12, 2023 · FDA recall Z-1331-2023 · Medtronic Sofamor Danek USA
Hazard
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. · FDA Class II
Units
10037 units
Sold at
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.
Description
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.
Product
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
Manufacturer(s)
Medtronic Sofamor Danek USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →