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

Products covered by this recall
Model / numberProduct as published
T50203ACCELERATE BG SET T50203 GRAFTON DBF 3CC
T50206ACCELERATE BG SET T50206 GRAFTON DBF 6CC
T50209ACCELERATE BG SET T50209 GRAFTON DBF 9CC
T50212ACCELERATE BG SET T50212 GRAFTON DBF12CC, ; Demineralized Bone Matrix (DBM) product
Lot codes and dates
    • a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC
    • REF T50203
    • GTIN 00763000244705
  • Serial Numbers

    410 of 410 codes

    • A45206-011
    • A45206-012
    • A45206-013
    • A45206-014
    • A45206-016
    • A45206-018
    • A45206-019
    • A45206-020
    • A45206-021
    • A45206-022
    • A45206-023
    • A45206-024
    • A45206-025
    • A45206-026
    • A45206-027
    • A45206-028
    • A45206-029
    • A45206-030
    • A45206-031
    • A45206-032
    • A45206-033
    • A45206-034
    • A45206-035
    • A45206-036
    • A45206-037
    • A45206-038
    • A45206-040
    • A45206-041
    • A45206-042
    • A45206-043
    • A45206-045
    • A45206-046
    • A45206-047
    • A45206-048
    • A45206-049
    • A45206-050
    • A45206-051
    • A45206-052
    • A45206-053
    • A45206-054
    • A45206-055
    • A45206-056
    • A45206-057
    • A45206-058
    • A45206-061
    • A45206-063
    • A45206-064
    • A45206-066
    • A45206-067
    • A45206-068
    • A45206-069
    • A45206-070
    • A45206-071
    • A45206-072
    • A45489-011
    • A45489-012
    • A45489-015
    • A45489-016
    • A45489-017
    • A45489-021
  • Serial Numbers

    1,554 of 1,554 codes

    • A42287-087
    • A42287-088
    • A42287-089
    • A42287-090
    • A42287-092
    • A42287-093
    • A42287-094
    • A42287-095
    • A42287-100
    • A42287-101
    • A42287-102
    • A42287-103
    • A42287-104
    • A42287-105
    • A42287-108
    • A42287-112
    • A42287-113
    • A42287-114
    • A42287-116
    • A42287-117
    • A42287-118
    • A42287-119
    • A42287-121
    • A42287-122
    • A42287-123
    • A42287-124
    • A42287-125
    • A42287-126
    • A42287-160
    • A42287-161
    • A42287-162
    • A42287-163
    • A42287-164
    • A42287-165
    • A42287-166
    • A42287-167
    • A45179-026
    • A45179-027
    • A45179-028
    • A45179-029
    • A45179-030
    • A45179-031
    • A45179-032
    • A45179-033
    • A45179-034
    • A45179-036
    • A45179-037
    • A45179-038
    • A45179-039
    • A45179-040
    • A45179-041
    • A45179-042
    • A45179-043
    • A45179-044
    • A45179-045
    • A45179-046
    • A45179-047
    • A45179-048
    • A45179-051
    • A45179-052
  • Serial Numbers

    643 of 643 codes

    • A45398-036
    • A45398-037
    • A45398-038
    • A45398-039
    • A45398-040
    • A45398-041
    • A45398-042
    • A45398-043
    • A45398-044
    • A45398-045
    • A45398-046
    • A45398-047
    • A45398-048
    • A45398-049
    • A46088-011
    • A46088-012
    • A46088-013
    • A46088-014
    • A46088-015
    • A46088-016
    • A46088-017
    • A46088-018
    • A46088-019
    • A46088-020
    • A46088-021
    • A46088-022
    • A46088-023
    • A46088-024
    • A46088-025
    • A46088-026
    • A46088-027
    • A46088-029
    • A46088-030
    • A46088-031
    • A46088-032
    • A46088-033
    • A46088-034
    • A46088-035
    • A46088-036
    • A46088-037
    • A46088-038
    • A46088-039
    • A46088-040
    • A46088-042
    • A46088-043
    • A46088-044
    • A46088-045
    • A46948-011
    • A46948-012
    • A46948-015
    • A46948-017
    • A46948-018
    • A46948-019
    • A46948-020
    • A46948-021
    • A46948-022
    • A46948-023
    • A46948-026
    • A46948-027
    • A46948-028
  • Serial Numbers

    87 of 87 codes

    • A45398-050
    • A45398-051
    • A45398-052
    • A45398-053
    • A45398-054
    • A45398-055
    • A45398-056
    • A45398-057
    • A45398-058
    • A45398-059
    • A45398-060
    • A45398-061
    • A45398-062
    • A45398-063
    • A45930-031
    • A45930-032
    • A45930-033
    • A45930-034
    • A45930-035
    • A45930-036
    • A45930-037
    • A45930-038
    • A45930-039
    • A45930-040
    • A45930-041
    • A45930-042
    • A45930-043
    • A45930-044
    • A45930-045
    • A45930-046
    • A45930-047
    • A45930-048
    • A45930-049
    • A45930-050
    • A45930-051
    • A45930-052
    • A47605-013
    • A47605-015
    • A47605-016
    • A47605-017
    • A47605-020
    • A47605-021
    • A47605-023
    • A47605-024
    • A47605-031
    • A47605-032
    • A47605-037
    • A47605-038
    • A47687-012
    • A47687-013
    • A47687-014
    • A47687-015
    • A47687-016
    • A47687-017
    • A47687-018
    • A47687-019
    • A47687-020
    • A47687-024
    • A47687-025
    • A47687-026
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.