Medtronic GRAFTON DBM Flex Recalled for Incorrect Product Dimensions
Medtronic is recalling GRAFTON DBM Flex units labeled as 2.5 cm x 10 cm that actually measure 2.5 cm x 5 cm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error regarding product dimensions without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 30 units of Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100. The product is an orthopaedic filler and bone void filler that is prescription-only and sterile.
The recall was initiated because the product was labeled as measuring 2.5 cm x 10 cm, but the actual product contained units that measured 2.5 cm x 5 cm. This discrepancy in dimensions is the stated reason for the recall.
The affected units were distributed in the United States in the states of Missouri, Florida, Minnesota, Ohio, Michigan, Texas, and New Jersey. The specific lot codes involved are A16707-098 through A16707-125, A16707-142, and A16707-147. Healthcare providers and patients should verify the dimensions of any implanted or stored units against the labeling and contact Medtronic or the FDA for further instructions.
The recalled product
- Product
- Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- A16707-098
- A16707-099
- A16707-100
- A16707-101
- A16707-102
- A16707-103
- A16707-104
- A16707-105
- A16707-106
- A16707-107
- A16707-108
- A16707-109
- A16707-110
- A16707-111
- A16707-112
- A16707-113
- A16707-114
- A16707-115
- A16707-116
- A16707-117
Distribution
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