Medtronic Bone Graft Recalled Due to Incorrect Size Labeling
Medtronic Sofamor Danek USA Inc is recalling Magnifuse Bone Graft products due to incorrect size labeling on 55 pouches. Units with specific serial numbers were distributed in nine U.S. states.
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: FDA Class II medical device recall of a surgical implant with size specification labeling error. This qualifies as a risk-of-harm product where injury or compromised surgical outcomes have not yet been reported per the severity rubric. No illnesses, injuries, or deaths are documented in the source text.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Magnifuse Bone Graft, Large (14mm x 25mm, REF 7509014), a demineralized bone matrix surgical implant. The recall was initiated because incorrect product labeling was applied, indicating the wrong size of product.
Approximately 55 pouches with serial numbers A57958-011 through A57958-086 (with gaps in the sequence) were affected. The products have an expiration date of February 15, 2025 and were distributed across nine U.S. states: Idaho, Indiana, Minnesota, North Carolina, New York, Ohio, Oregon, Washington, and Wisconsin.
Healthcare facilities and medical professionals in the affected states should verify the actual product size and take appropriate action regarding affected units. The FDA classified this as a Class II recall.
The recalled product
- Product
- Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 55
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)
- Serial numbers: A57958-011
- A57958-012
- A57958-013
- A57958-014
- A57958-015
- A57958-016
- A57958-017
- A57958-018
- A57958-019
- A57958-020
- A57958-021
- A57958-022
- A57958-023
- A57958-024
- A57958-025
- A57958-026
- A57958-027
- A57958-028
- A57958-029
- A57958-030
Distribution
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