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E3D-A Interbody System
Evolution Spine LLC · Model 111H-L1514 · UDI-DI 20195860022010
2
510(k) clearances
1,268
Adverse events (11 deaths)
36
Recalls
254
Facilities
Description
HAnano STATIC Ti ALIF 40 X 28mm 15deg 14mm (P 6mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | Novapproach Spine, LLC | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-01-03 | XTANT Medical Holdings, Inc | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. |
| 2024-07-15 | Omnia Medical | Failure of fusion system instruments in the field. |
| 2024-07-15 | Omnia Medical | Failure of fusion system instruments in the field. |
| 2024-01-26 | Alphatec Spine, Inc. | Due to reports of intraoperative graft bolt implantation breakages. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.