Reported Apr 12, 2023 · Ongoing

Medtronic Grafton Flex

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 Flex

10 of 10 products

Products covered by this recall
Model / numberProduct as published
S42090DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX
T42090DBM T42090 1.5CMX1.5CM FLEX GRAFTON
T42090INTDBM T42090INT 1.5CMX1.5CM FLEX GRAFTON
T42100DBM T42100 2.5CMX10CM FLEX GRAFTON
T42100AUSDBM T42100AUS 2.5CMX10CM FLEX GRAFTON
T42100INTDBM T42100INT 2.5CMX10CM FLEX GRAFTON
T42110DBM T42110 2.5CMX5CM FLEXGRAFTON
T42110AUSDBM T42110AUS 2.5CMX5CM FLEX GRAFTON
T42110INTDBM T42110INT 2.5CMX5CM FLEXGRAFTON
T42150INTDBM T42150INT 5CM X 5CM FLEX GRAFTON, ; Demineralized Bone Matrix (DBM) product
Lot codes and dates
    • a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX
    • REF S42090
    • GTIN 00613994961006
  • Serial Numbers
    • A50360
    • A52104
    • A55429
    • b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON
    • REF T42090
    • GTIN 00643169122994
  • Serial Numbers

    343 of 343 codes

    • A40174-066
    • A40174-067
    • A40174-068
    • A40174-069
    • A40174-070
    • A40174-071
    • A40174-072
    • A40174-073
    • A40174-074
    • A40174-075
    • A40174-076
    • A40174-077
    • A40174-078
    • A40174-079
    • A42594-022
    • A42594-023
    • A42594-024
    • A42594-025
    • A42594-026
    • A42594-027
    • A42594-028
    • A42594-029
    • A42594-030
    • A42594-031
    • A42594-032
    • A42594-033
    • A42594-034
    • A42594-035
    • A42594-036
    • A42594-037
    • A42890-011
    • A42890-012
    • A42890-013
    • A42890-014
    • A42890-015
    • A42890-016
    • A42890-017
    • A42890-018
    • A42890-019
    • A42890-020
    • A42890-021
    • A42890-022
    • A42890-023
    • A42890-024
    • A43119-101
    • A43119-102
    • A43119-103
    • A43119-104
    • A43119-105
    • A43220-011
    • A43220-012
    • A44574-011
    • A44574-012
    • A44574-013
    • A44574-014
    • A44574-015
    • A44574-016
    • A44616-011
    • A44616-012
    • A44616-013
  • Serial Numbers

    174 of 174 codes

    • A42232-041
    • A42232-042
    • A42232-043
    • A42232-044
    • A42232-045
    • A42232-046
    • A42232-047
    • A42232-048
    • A42232-049
    • A42232-050
    • A42232-051
    • A42232-052
    • A42232-053
    • A42232-054
    • A42232-055
    • A42232-056
    • A42232-057
    • A42232-058
    • A42232-059
    • A42232-060
    • A42232-061
    • A42232-062
    • A42232-063
    • A42851-038
    • A42851-039
    • A42851-040
    • A42851-041
    • A42851-042
    • A42851-043
    • A42851-044
    • A42851-045
    • A42851-046
    • A42851-047
    • A42851-048
    • A42851-049
    • A42851-050
    • A42851-051
    • A42851-052
    • A43708-049
    • A43708-050
    • A43708-051
    • A43708-052
    • A43708-053
    • A43708-054
    • A43708-055
    • A43708-056
    • A43708-057
    • A43708-058
    • A43708-059
    • A43708-060
    • A43708-061
    • A43708-062
    • A43708-063
    • A43708-064
    • A43708-065
    • A43708-066
    • A43708-067
    • A43708-068
    • A43708-069
    • A43708-070
  • Serial Numbers

    1,231 of 1,231 codes

    • A41864-011
    • A41864-012
    • A41864-013
    • A41864-014
    • A41864-015
    • A41864-016
    • A41864-017
    • A41864-018
    • A41864-019
    • A41864-020
    • A41864-021
    • A42890-025
    • A42890-026
    • A42890-027
    • A42890-028
    • A42890-029
    • A42890-030
    • A42890-031
    • A42890-032
    • A42890-033
    • A42890-034
    • A42890-035
    • A42890-036
    • A42890-037
    • A42890-038
    • A42964-021
    • A42964-022
    • A42964-023
    • A42964-024
    • A42964-025
    • A42964-026
    • A42964-027
    • A42964-028
    • A42964-029
    • A42972-061
    • A42972-062
    • A42972-063
    • A42972-064
    • A42972-065
    • A42972-066
    • A42972-067
    • A42972-068
    • A42972-069
    • A42972-070
    • A42972-071
    • A42972-072
    • A42972-073
    • A42972-074
    • A42972-075
    • A42972-076
    • A43119-106
    • A43119-107
    • A43119-108
    • A43119-109
    • A43119-110
    • A43119-111
    • A43119-112
    • A43119-113
    • A43119-114
    • A43119-115
  • Serial Numbers

    190 of 190 codes

    • A43708-045
    • A43708-046
    • A43708-047
    • A43708-048
    • A43995-011
    • A43995-012
    • A43995-013
    • A43995-014
    • A43995-015
    • A43995-016
    • A43995-017
    • A43995-018
    • A43995-019
    • A43995-020
    • A43995-021
    • A43995-022
    • A43995-023
    • A43995-024
    • A43995-025
    • A43995-026
    • A43995-027
    • A43995-028
    • A43995-029
    • A43995-030
    • A43995-031
    • A43995-032
    • A43995-033
    • A43995-034
    • A43995-035
    • A43995-036
    • A43995-037
    • A43995-038
    • A43995-039
    • A43995-040
    • A43995-041
    • A44446-066
    • A44446-067
    • A44446-068
    • A44446-069
    • A44446-070
    • A44446-071
    • A44446-072
    • A44446-073
    • A44446-074
    • A44446-075
    • A44446-076
    • A44446-077
    • A44446-078
    • A44446-079
    • A44446-080
    • A44446-081
    • A44446-082
    • A44446-083
    • A44446-084
    • A44446-085
    • A44446-086
    • A44446-087
    • A44446-088
    • A44446-089
    • A44446-090
  • Serial Numbers
    • A41864-022
    • A41864-025
    • A43220-014
    • A43220-015
    • A43220-016
    • A43220-017
    • A43220-018
    • A43220-019
    • A43220-020
    • A43220-021
    • A43220-022
    • A43220-023
    • A43220-024
    • A43220-025
    • A43220-026
    • A43220-027
    • A46552-025
    • A46991-046
    • A47264-042
    • A49099-011
    • A49099-012
    • A49099-013
    • A49099-014
    • A49099-015
    • A51978-025
    • A52104-064
    • A52104-065
    • A52104-066
    • A52981-070
    • A53349-081
    • A53349-082
    • A53349-083
    • A54391-044
    • A55429-033
    • A55429-034
    • A55429-035
    • A55429-036
    • A55429-037
    • A55429-038
    • A55429-039
    • A55429-040
    • A55429-041
    • A55429-042
    • g) DBM T42110 2.5CMX5CM FLEXGRAFTON
    • REF T42110
    • GTIN 00643169123014
  • Serial Numbers

    692 of 692 codes

    • A40174-080
    • A40174-081
    • A40174-082
    • A40174-083
    • A40174-084
    • A40174-085
    • A40174-086
    • A40174-087
    • A40174-088
    • A40174-089
    • A40174-090
    • A40174-091
    • A40174-092
    • A40174-093
    • A40174-094
    • A40174-095
    • A40174-096
    • A40174-097
    • A40174-098
    • A40174-099
    • A40174-100
    • A40174-101
    • A40174-102
    • A40174-103
    • A41995-094
    • A41995-095
    • A41995-096
    • A41995-097
    • A41995-098
    • A41995-099
    • A41995-100
    • A41995-101
    • A41995-102
    • A41995-103
    • A41995-104
    • A41995-105
    • A41995-106
    • A41995-107
    • A41995-108
    • A41995-109
    • A41995-110
    • A41995-111
    • A41995-112
    • A41995-113
    • A41995-114
    • A41995-115
    • A41995-116
    • A41995-117
    • A42328-024
    • A42328-025
    • A42328-026
    • A42328-027
    • A42328-028
    • A42328-029
    • A42328-030
    • A42328-031
    • A42328-032
    • A42328-033
    • A42328-034
    • A42328-035
Amount recalled
2987 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, 7:38 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.