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iFuse Bedrock Granite Implant System
Si-Bone Inc. · Model 095115CH · UDI-DI 00810055524105
1
510(k) clearances
1,410
Adverse events (5 deaths)
2
Recalls
159
Facilities
Description
9.5 mm x 115 mm iFuse Bedrock Granite Closed Head Implant
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | SI-BONE, Inc. | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
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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.