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
| Model / number | Product as published |
|---|---|
S41120 | DBM S41120 GRAFTON GEL 1CC |
S41150 | DBM S41150 GRAFTON GEL 10CC |
T41110 | DBM T41110 0.5CC GRAFTON GEL |
T41110INT | DBM T41110INT 0.5CC GRAFTON GEL |
T41120 | DBM T41120 1CC GRAFTON GEL |
T41120INT | DBM T41120INT 1CC GRAFTON GEL |
T41130 | DBM T41130 5CC GRAFTON GEL |
T41130INT | DBM T41130INT 5CC GRAFTON GEL |
T41150 | DBM T41150 10CC GRAFTON GEL |
T41150INT | DBM T41150INT 10CC GRAFTON GEL, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S41120 GRAFTON GEL 1CCREF S41120GTIN 00613994961167
- Serial Numbers
A41879 b) DBM S41150 GRAFTON GEL 10CCREF S41150GTIN 00613994961143
- Serial Numbers
A43939A47225 c) DBM T41110 0.5CC GRAFTON GELREF T41110GTIN 00643169122956
- Serial Numbers
663 of 663 codes
A38528-100A38528-101A38528-102A38528-103A38528-104A38528-105A38528-106A38910-058A38910-059A38910-060A38910-061A38910-062A41224-053A41224-054A41224-055A41224-056A41224-057A41224-058A41224-059A41224-060A41224-061A41224-062A41224-063A41224-064A41224-065A41224-066A41224-067A41224-068A41224-069A41224-070A41224-071A41224-072A41935-025A41935-026A41935-027A41935-028A41935-029A41935-030A41935-031A41935-032A41935-033A41935-034A41935-035A41935-036A41935-037A41935-038A41935-039A41935-040A41935-041A41935-042A41935-043A41935-044A41935-045A41935-046A41935-047A41935-048A41935-049A41935-050A41935-051A41935-052
- Serial Numbers
372 of 372 codes
A37724-094A37724-095A37724-096A37724-097A37724-098A37724-099A37724-100A37724-101A37724-102A37724-103A37724-104A37724-105A37724-106A37724-107A37724-108A37724-109A37724-110A37724-111A37724-112A37724-113A37724-114A37724-115A37724-116A37724-117A37724-118A37724-119A37724-120A37724-121A37724-122A37724-123A37724-124A37724-125A37724-126A39537-031A39537-032A39537-033A39537-034A39537-035A39537-036A39537-037A39537-038A39537-039A39537-040A39537-041A39537-042A39537-043A39537-044A39537-045A39537-046A39537-047A39537-048A39537-049A39537-050A39537-051A39537-052A39537-053A42444-041A42444-042A42444-043A42444-044
- Serial Numbers
1,651 of 1,651 codes
A38528-107A38528-108A38528-109A38528-110A38528-111A38528-112A38528-113A38528-114A38528-115A38528-116A38528-117A38528-118A38528-119A38528-120A38528-121A38528-122A38528-123A38528-124A38528-125A38528-126A38528-127A38528-128A38528-129A38528-130A38528-132A38528-133A38528-134A38528-135A38528-136A38528-137A38528-138A38528-139A38528-140A38528-141A38528-142A38528-143A38528-144A38528-145A38528-146A38528-147A38528-148A38528-149A38528-150A38528-151A38528-152A38528-153A38528-154A38528-155A38528-156A38528-157A38528-158A38528-159A38528-160A38528-161A38528-162A38528-163A38528-165A38528-166A38528-167A38528-168
- 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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