Reported Apr 12, 2023 · Ongoing

Medtronic Grafton Gel

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 Gel

10 of 10 products

Products covered by this recall
Model / numberProduct as published
S41120DBM S41120 GRAFTON GEL 1CC
S41150DBM S41150 GRAFTON GEL 10CC
T41110DBM T41110 0.5CC GRAFTON GEL
T41110INTDBM T41110INT 0.5CC GRAFTON GEL
T41120DBM T41120 1CC GRAFTON GEL
T41120INTDBM T41120INT 1CC GRAFTON GEL
T41130DBM T41130 5CC GRAFTON GEL
T41130INTDBM T41130INT 5CC GRAFTON GEL
T41150DBM T41150 10CC GRAFTON GEL
T41150INTDBM T41150INT 10CC GRAFTON GEL, ; Demineralized Bone Matrix (DBM) product
Lot codes and dates
    • a) DBM S41120 GRAFTON GEL 1CC
    • REF S41120
    • GTIN 00613994961167
  • Serial Numbers
    • A41879 b) DBM S41150 GRAFTON GEL 10CC
    • REF S41150
    • GTIN 00613994961143
  • Serial Numbers
    • A43939
    • A47225 c) DBM T41110 0.5CC GRAFTON GEL
    • REF T41110
    • GTIN 00643169122956
  • Serial Numbers

    663 of 663 codes

    • A38528-100
    • A38528-101
    • A38528-102
    • A38528-103
    • A38528-104
    • A38528-105
    • A38528-106
    • A38910-058
    • A38910-059
    • A38910-060
    • A38910-061
    • A38910-062
    • A41224-053
    • A41224-054
    • A41224-055
    • A41224-056
    • A41224-057
    • A41224-058
    • A41224-059
    • A41224-060
    • A41224-061
    • A41224-062
    • A41224-063
    • A41224-064
    • A41224-065
    • A41224-066
    • A41224-067
    • A41224-068
    • A41224-069
    • A41224-070
    • A41224-071
    • A41224-072
    • A41935-025
    • A41935-026
    • A41935-027
    • A41935-028
    • A41935-029
    • A41935-030
    • A41935-031
    • A41935-032
    • A41935-033
    • A41935-034
    • A41935-035
    • A41935-036
    • A41935-037
    • A41935-038
    • A41935-039
    • A41935-040
    • A41935-041
    • A41935-042
    • A41935-043
    • A41935-044
    • A41935-045
    • A41935-046
    • A41935-047
    • A41935-048
    • A41935-049
    • A41935-050
    • A41935-051
    • A41935-052
  • Serial Numbers

    372 of 372 codes

    • A37724-094
    • A37724-095
    • A37724-096
    • A37724-097
    • A37724-098
    • A37724-099
    • A37724-100
    • A37724-101
    • A37724-102
    • A37724-103
    • A37724-104
    • A37724-105
    • A37724-106
    • A37724-107
    • A37724-108
    • A37724-109
    • A37724-110
    • A37724-111
    • A37724-112
    • A37724-113
    • A37724-114
    • A37724-115
    • A37724-116
    • A37724-117
    • A37724-118
    • A37724-119
    • A37724-120
    • A37724-121
    • A37724-122
    • A37724-123
    • A37724-124
    • A37724-125
    • A37724-126
    • A39537-031
    • A39537-032
    • A39537-033
    • A39537-034
    • A39537-035
    • A39537-036
    • A39537-037
    • A39537-038
    • A39537-039
    • A39537-040
    • A39537-041
    • A39537-042
    • A39537-043
    • A39537-044
    • A39537-045
    • A39537-046
    • A39537-047
    • A39537-048
    • A39537-049
    • A39537-050
    • A39537-051
    • A39537-052
    • A39537-053
    • A42444-041
    • A42444-042
    • A42444-043
    • A42444-044
  • Serial Numbers

    1,651 of 1,651 codes

    • A38528-107
    • A38528-108
    • A38528-109
    • A38528-110
    • A38528-111
    • A38528-112
    • A38528-113
    • A38528-114
    • A38528-115
    • A38528-116
    • A38528-117
    • A38528-118
    • A38528-119
    • A38528-120
    • A38528-121
    • A38528-122
    • A38528-123
    • A38528-124
    • A38528-125
    • A38528-126
    • A38528-127
    • A38528-128
    • A38528-129
    • A38528-130
    • A38528-132
    • A38528-133
    • A38528-134
    • A38528-135
    • A38528-136
    • A38528-137
    • A38528-138
    • A38528-139
    • A38528-140
    • A38528-141
    • A38528-142
    • A38528-143
    • A38528-144
    • A38528-145
    • A38528-146
    • A38528-147
    • A38528-148
    • A38528-149
    • A38528-150
    • A38528-151
    • A38528-152
    • A38528-153
    • A38528-154
    • A38528-155
    • A38528-156
    • A38528-157
    • A38528-158
    • A38528-159
    • A38528-160
    • A38528-161
    • A38528-162
    • A38528-163
    • A38528-165
    • A38528-166
    • A38528-167
    • A38528-168
Amount recalled
10090 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, 7:34 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.