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
| Model / number | Product as published |
|---|---|
S42090 | DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX |
T42090 | DBM T42090 1.5CMX1.5CM FLEX GRAFTON |
T42090INT | DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON |
T42100 | DBM T42100 2.5CMX10CM FLEX GRAFTON |
T42100AUS | DBM T42100AUS 2.5CMX10CM FLEX GRAFTON |
T42100INT | DBM T42100INT 2.5CMX10CM FLEX GRAFTON |
T42110 | DBM T42110 2.5CMX5CM FLEXGRAFTON |
T42110AUS | DBM T42110AUS 2.5CMX5CM FLEX GRAFTON |
T42110INT | DBM T42110INT 2.5CMX5CM FLEXGRAFTON |
T42150INT | DBM T42150INT 5CM X 5CM FLEX GRAFTON, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEXREF S42090GTIN 00613994961006
- Serial Numbers
A50360A52104A55429b) DBM T42090 1.5CMX1.5CM FLEX GRAFTONREF T42090GTIN 00643169122994
- Serial Numbers
343 of 343 codes
A40174-066A40174-067A40174-068A40174-069A40174-070A40174-071A40174-072A40174-073A40174-074A40174-075A40174-076A40174-077A40174-078A40174-079A42594-022A42594-023A42594-024A42594-025A42594-026A42594-027A42594-028A42594-029A42594-030A42594-031A42594-032A42594-033A42594-034A42594-035A42594-036A42594-037A42890-011A42890-012A42890-013A42890-014A42890-015A42890-016A42890-017A42890-018A42890-019A42890-020A42890-021A42890-022A42890-023A42890-024A43119-101A43119-102A43119-103A43119-104A43119-105A43220-011A43220-012A44574-011A44574-012A44574-013A44574-014A44574-015A44574-016A44616-011A44616-012A44616-013
- Serial Numbers
174 of 174 codes
A42232-041A42232-042A42232-043A42232-044A42232-045A42232-046A42232-047A42232-048A42232-049A42232-050A42232-051A42232-052A42232-053A42232-054A42232-055A42232-056A42232-057A42232-058A42232-059A42232-060A42232-061A42232-062A42232-063A42851-038A42851-039A42851-040A42851-041A42851-042A42851-043A42851-044A42851-045A42851-046A42851-047A42851-048A42851-049A42851-050A42851-051A42851-052A43708-049A43708-050A43708-051A43708-052A43708-053A43708-054A43708-055A43708-056A43708-057A43708-058A43708-059A43708-060A43708-061A43708-062A43708-063A43708-064A43708-065A43708-066A43708-067A43708-068A43708-069A43708-070
- Serial Numbers
1,231 of 1,231 codes
A41864-011A41864-012A41864-013A41864-014A41864-015A41864-016A41864-017A41864-018A41864-019A41864-020A41864-021A42890-025A42890-026A42890-027A42890-028A42890-029A42890-030A42890-031A42890-032A42890-033A42890-034A42890-035A42890-036A42890-037A42890-038A42964-021A42964-022A42964-023A42964-024A42964-025A42964-026A42964-027A42964-028A42964-029A42972-061A42972-062A42972-063A42972-064A42972-065A42972-066A42972-067A42972-068A42972-069A42972-070A42972-071A42972-072A42972-073A42972-074A42972-075A42972-076A43119-106A43119-107A43119-108A43119-109A43119-110A43119-111A43119-112A43119-113A43119-114A43119-115
- Serial Numbers
190 of 190 codes
A43708-045A43708-046A43708-047A43708-048A43995-011A43995-012A43995-013A43995-014A43995-015A43995-016A43995-017A43995-018A43995-019A43995-020A43995-021A43995-022A43995-023A43995-024A43995-025A43995-026A43995-027A43995-028A43995-029A43995-030A43995-031A43995-032A43995-033A43995-034A43995-035A43995-036A43995-037A43995-038A43995-039A43995-040A43995-041A44446-066A44446-067A44446-068A44446-069A44446-070A44446-071A44446-072A44446-073A44446-074A44446-075A44446-076A44446-077A44446-078A44446-079A44446-080A44446-081A44446-082A44446-083A44446-084A44446-085A44446-086A44446-087A44446-088A44446-089A44446-090
- Serial Numbers
A41864-022A41864-025A43220-014A43220-015A43220-016A43220-017A43220-018A43220-019A43220-020A43220-021A43220-022A43220-023A43220-024A43220-025A43220-026A43220-027A46552-025A46991-046A47264-042A49099-011A49099-012A49099-013A49099-014A49099-015A51978-025A52104-064A52104-065A52104-066A52981-070A53349-081A53349-082A53349-083A54391-044A55429-033A55429-034A55429-035A55429-036A55429-037A55429-038A55429-039A55429-040A55429-041A55429-042g) DBM T42110 2.5CMX5CM FLEXGRAFTONREF T42110GTIN 00643169123014
- Serial Numbers
692 of 692 codes
A40174-080A40174-081A40174-082A40174-083A40174-084A40174-085A40174-086A40174-087A40174-088A40174-089A40174-090A40174-091A40174-092A40174-093A40174-094A40174-095A40174-096A40174-097A40174-098A40174-099A40174-100A40174-101A40174-102A40174-103A41995-094A41995-095A41995-096A41995-097A41995-098A41995-099A41995-100A41995-101A41995-102A41995-103A41995-104A41995-105A41995-106A41995-107A41995-108A41995-109A41995-110A41995-111A41995-112A41995-113A41995-114A41995-115A41995-116A41995-117A42328-024A42328-025A42328-026A42328-027A42328-028A42328-029A42328-030A42328-031A42328-032A42328-033A42328-034A42328-035
- 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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.