Food, drugs, devices › Medtronic Sofamor Danek USA Inc
Device recall: Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
FDA enforcement event 93163 is a device recall by Medtronic Sofamor Danek USA Inc of Memphis, TN, initiated 26 Sep 2023 and classified Class II, with 7 product records.
FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Sofamor Danek USA Inc has 31 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Sofamor Danek USA Inc, Memphis, TN.
Reason for recall
"Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch."
Distribution
"US, Colombia, S. Korea, New Zealand, India, Taiwan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0161-2024 | Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix | 84 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0162-2024 | Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix | 77 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0163-2024 | Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix | 377 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0164-2024 | Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix | 282 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0165-2024 | Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix | 430 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0166-2024 | Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix | 583 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0167-2024 | Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix | N/A | Class II | Ongoing | 1 Nov 2023 |
Context
Other enforcement events for Medtronic Sofamor Danek USA Inc
All 31 events for Medtronic Sofamor Danek USA Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US, Colombia, S. Korea, New Zealand, India, Taiwan"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.