RecallReported October 21, 2026
Class II recall by Medtronic Sofamor Danek USA Inc
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone mat…
FDA's enforcement report of October 21, 2026 lists a Class II recall by Medtronic Sofamor Danek USA Inc of Memphis, TN. Product: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone mat…. Status: Ongoing.
On the record
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Location
- Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-0138-2027
- Product type
- Devices
- Recall initiated
- 2026-08-12
- Reported by FDA
- 2026-10-21
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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