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Unity
DIOMEDICAL CO.,LTD. · Model A · UDI-DI 08800113960190
OUR
Prescription
1
510(k) clearances
1,406
Adverse events (5 deaths)
1
Recalls
154
Facilities
Description
Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)35x(B)9.5x(C)2.9x(D)2.6x(E)4.5x(F)6.3mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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.