Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc
Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc (Tennessee): Medtronic Sofamor Danek USA Inc. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 8 related TN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0138-2027 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are produced from a fiber form of DBM Crunch" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are |
| Reason | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection. |
| Quantity | 20 |
| Distribution | US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA. |
| Recall initiated | 2026-08-12 |
| Reported | 2026-10-21 |
| Firm location | Memphis, TN, United States |
| Peer records CSV (9 TN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc and 9 Tennessee peers
- Tennessee FDAPulse records like this one: 9
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Tennessee peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.
What is the FDAPulse record for Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc in Tennessee?
Class II device recall Z-0138-2027 by Medtronic Sofamor Danek USA Inc: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic do
How does Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc compare to other Tennessee FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0138-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0138-2027 | TN | 2026-10-21 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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