Medtronic Grafton Gel Surgical Implant Sterile Barrier Packaging Recall
Medtronic is recalling Grafton Gel demineralized bone matrix surgical implants due to packaging non-conformances in the sterile pouch that could compromise the sterile barrier of the implant.
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 a Class II FDA recall of an implantable surgical device with potential sterile barrier defects. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High). The hazard is theoretical, involving a potential breach of the sterile barrier with no reported illnesses or injuries.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling multiple lot numbers of Medtronic Grafton Gel, a demineralized bone matrix (DBM) surgical implant used in orthopedic and spine surgery procedures. The recall affects approximately 10,090 units of the product distributed worldwide, including throughout the United States and many other countries.
The recall has been issued due to potential non-conformances in the dual-barrier, sterile pouch packaging system. These packaging defects could lead to a breach in the sterile barrier that protects the implant from contamination.
Patients who have received this implant, healthcare providers, and facilities that may have these products in inventory should contact Medtronic for information regarding this recall. This is a Class II recall issued by the FDA.
The recalled product
- Product
- Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120IN
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 10,090
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) DBM S41120 GRAFTON GEL 1CC
- REF S41120
- GTIN 00613994961167
- Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC
- REF S41150
- GTIN 00613994961143
- Serial Numbers: A43939
- A47225 c) DBM T41110 0.5CC GRAFTON GEL
- REF T41110
- GTIN 00643169122956
- Serial Numbers: A38528-100
- A38528-101
- A38528-102
- A38528-103
- A38528-104
- A38528-105
- A38528-106
- A38910-058
- A38910-059
- A38910-060
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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