Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects
Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a risk-of-harm product where packaging defects could compromise sterility. Per the rubric, theoretical hazards without reported injury score at most 3 (High).
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Grafton DBF Inject, a demineralized bone matrix product used in surgical procedures. The recall affects approximately 10,037 units distributed worldwide, including units in the United States, Canada, Europe, and numerous other countries. The product is available in three sizes: the 3CC, 6CC, and 9CC formulations, each identified by specific reference numbers and serial numbers.
The recall is due to potential non-conformances in the dual-barrier, sterile pouch packaging system. Non-conforming packaging may compromise the sterile barrier integrity of the product.
Healthcare providers and patients with these products should contact Medtronic Sofamor Danek USA Inc or their healthcare provider for information about affected serial numbers and appropriate management of distributed units. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- sterile-barrier-breach
- packaging-defect
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)
- a) GRAFTON T50303 DBF INJECT 3CC
- REF T50303
- GTIN 00763000254001
- Serial Numbers: A44493-011
- A44493-012
- A44493-013
- A44493-014
- A44493-015
- A44493-016
- A44493-017
- A44493-018
- A44493-019
- A44493-020
- A44493-021
- A44493-022
- A44493-023
- A44493-025
- A44493-028
- A44591-011
- A44591-012
Distribution
Distributed nationwide across the United States.
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