Grafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
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 3/5 (High).
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 a potential failure to perform required inspection of the sterile barrier on an implantable medical device. The critical importance of proper sterile packaging for implantable devices classifies this as High severity.
Plain-English summary
Grafton DBM (Flex) is a demineralized bone matrix product used in orthopedic and spinal surgery. Medtronic Sofamor Danek USA Inc. is recalling 77 units (Model T42100, GTIN 00643169123007) due to potential non-conformances in the outer Tyvek sterile pouch.
A required inspection step of the outer Tyvek pouch may not have been performed according to manufacturing requirements. This means certain batches may have been released without proper validation of the sterile barrier packaging.
The recalled units were distributed to the United States, Colombia, South Korea, New Zealand, India, and Taiwan. Patients and healthcare providers with affected serial numbers should contact Medtronic for instructions on product replacement or return.
The recalled product
- Product
- Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 77
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)
- GTIN 00643169123007
- Serial Numbers: A57164-040
- A58820-011
- A57164-041
- A57164-042
- A59190-046
- A59190-041
- A59190-042
- A59190-043
- A59190-044
- A59190-045
- A57164-026
- A57164-027
- A57164-028
- A57164-029
- A57164-030
- A57164-031
- A57164-032
- A57164-033
- A58820-017
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 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.
See all 7 products in this recall →Related recalls
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