Reported Apr 12, 2023 · Ongoing
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206…
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?
4 of 4 products
| Model / number | Product as published |
|---|---|
T50203 | ACCELERATE BG SET T50203 GRAFTON DBF 3CC |
T50206 | ACCELERATE BG SET T50206 GRAFTON DBF 6CC |
T50209 | ACCELERATE BG SET T50209 GRAFTON DBF 9CC |
T50212 | ACCELERATE BG SET T50212 GRAFTON DBF12CC, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) ACCELERATE BG SET T50203 GRAFTON DBF 3CCREF T50203GTIN 00763000244705
- Serial Numbers
410 of 410 codes
A45206-011A45206-012A45206-013A45206-014A45206-016A45206-018A45206-019A45206-020A45206-021A45206-022A45206-023A45206-024A45206-025A45206-026A45206-027A45206-028A45206-029A45206-030A45206-031A45206-032A45206-033A45206-034A45206-035A45206-036A45206-037A45206-038A45206-040A45206-041A45206-042A45206-043A45206-045A45206-046A45206-047A45206-048A45206-049A45206-050A45206-051A45206-052A45206-053A45206-054A45206-055A45206-056A45206-057A45206-058A45206-061A45206-063A45206-064A45206-066A45206-067A45206-068A45206-069A45206-070A45206-071A45206-072A45489-011A45489-012A45489-015A45489-016A45489-017A45489-021
- Serial Numbers
1,554 of 1,554 codes
A42287-087A42287-088A42287-089A42287-090A42287-092A42287-093A42287-094A42287-095A42287-100A42287-101A42287-102A42287-103A42287-104A42287-105A42287-108A42287-112A42287-113A42287-114A42287-116A42287-117A42287-118A42287-119A42287-121A42287-122A42287-123A42287-124A42287-125A42287-126A42287-160A42287-161A42287-162A42287-163A42287-164A42287-165A42287-166A42287-167A45179-026A45179-027A45179-028A45179-029A45179-030A45179-031A45179-032A45179-033A45179-034A45179-036A45179-037A45179-038A45179-039A45179-040A45179-041A45179-042A45179-043A45179-044A45179-045A45179-046A45179-047A45179-048A45179-051A45179-052
- Serial Numbers
643 of 643 codes
A45398-036A45398-037A45398-038A45398-039A45398-040A45398-041A45398-042A45398-043A45398-044A45398-045A45398-046A45398-047A45398-048A45398-049A46088-011A46088-012A46088-013A46088-014A46088-015A46088-016A46088-017A46088-018A46088-019A46088-020A46088-021A46088-022A46088-023A46088-024A46088-025A46088-026A46088-027A46088-029A46088-030A46088-031A46088-032A46088-033A46088-034A46088-035A46088-036A46088-037A46088-038A46088-039A46088-040A46088-042A46088-043A46088-044A46088-045A46948-011A46948-012A46948-015A46948-017A46948-018A46948-019A46948-020A46948-021A46948-022A46948-023A46948-026A46948-027A46948-028
- Serial Numbers
87 of 87 codes
A45398-050A45398-051A45398-052A45398-053A45398-054A45398-055A45398-056A45398-057A45398-058A45398-059A45398-060A45398-061A45398-062A45398-063A45930-031A45930-032A45930-033A45930-034A45930-035A45930-036A45930-037A45930-038A45930-039A45930-040A45930-041A45930-042A45930-043A45930-044A45930-045A45930-046A45930-047A45930-048A45930-049A45930-050A45930-051A45930-052A47605-013A47605-015A47605-016A47605-017A47605-020A47605-021A47605-023A47605-024A47605-031A47605-032A47605-037A47605-038A47687-012A47687-013A47687-014A47687-015A47687-016A47687-017A47687-018A47687-019A47687-020A47687-024A47687-025A47687-026
- Amount recalled
- 3037 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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