Reported Apr 12, 2023 · Ongoing
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF…
Medtronic Sofamor Danek USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
- Medtronic Grafton DBF Inject
a) GRAFTON T50303 DBF INJECT 3CCREF T50303b) GRAFTON T50306 DBF INJECT 6CCREF T50306c) GRAFTON T50309 DBF INJECT 9CCREF T50309Demineralized Bone Matrix (DBM) product
- Lot codes and dates
a) GRAFTON T50303 DBF INJECT 3CCREF T50303GTIN 00763000254001
- Serial Numbers
2,130 of 2,130 codes
A44493-011A44493-012A44493-013A44493-014A44493-015A44493-016A44493-017A44493-018A44493-019A44493-020A44493-021A44493-022A44493-023A44493-025A44493-028A44591-011A44591-012A44591-013A44591-014A44591-015A44591-016A44591-017A44591-018A44591-019A44591-020A44591-021A44591-022A44591-023A44591-024A44591-025A44591-026A44591-027A44591-028A44591-029A44591-030A44591-031A44591-032A44591-033A44591-034A44591-035A44591-036A44591-037A44591-039A44591-041A44591-042A44591-043A44591-044A44591-045A44591-046A44591-047A44591-048A44591-049A44591-050A44591-051A44591-052A44591-053A44591-054A44591-055A44591-056A44591-057
- Serial Numbers
576 of 576 codes
A46588-011A46588-012A46588-013A46588-014A46588-015A46588-016A46588-017A46588-018A46588-019A46588-020A46588-021A46588-022A46588-023A46588-024A46588-025A46588-026A46588-027A46588-028A46588-029A46588-030A46588-031A46588-032A46588-033A46588-034A46588-035A46588-036A46588-037A46588-038A46588-039A46588-040A46588-041A46588-042A46588-043A46655-011A46655-012A46655-013A46655-014A46655-015A46655-016A46655-017A46655-018A46655-019A46655-020A46655-022A46655-023A46655-024A46655-025A46655-026A46655-027A46655-028A46655-029A46655-030A46655-031A46655-032A46655-033A46655-034A46655-035A46655-036A46655-037A46655-038
- Amount recalled
- 10037 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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