Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall
Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.
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 recall involving potential sterile barrier compromise in a medical implant. However, no illnesses or injuries have been reported, placing it in the High severity category for risk-of-harm products without reported actual harm.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling multiple batches of Grafton DBF (Demineralized Bone Matrix), an implantable surgical product used in bone grafting procedures. The recall affects 47,436 units distributed worldwide, including throughout the United States and numerous international locations.
The recall is due to potential non-conformances in the dual-barrier sterile pouch packaging system used for these products. These packaging defects could compromise the sterile barrier, which is critical for maintaining product safety and sterility.
Healthcare providers who have received affected Grafton DBF products should identify them using the product serial numbers provided in the recall notice. No illnesses or injuries have been reported associated with this packaging defect.
The recalled product
- Product
- Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) P
- 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) PUTTY T50101 GRAFTON DBF 1CC
- REF T50101
- GTIN 00643169656017
- Serial Numbers: A40005-036
- A40005-037
- A40005-038
- A40005-039
- A40005-040
- A40005-041
- A40005-042
- A40005-043
- A40005-045
- A40005-046
- A40005-047
- A40005-048
- A40005-049
- A40005-051
- A40005-053
- A40005-054
- A40005-055
Distribution
Distributed nationwide across the United States.
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