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DePuy Synthes Sigma HP Uni Tib Cut Blk RM LL
No active recall
Manufacturer: DePuy Synthes · FDA product code: HTZ · Category: Instrument, Cutting, Orthopedic
Severity Snapshot
42 total reports2016-11 – 2025-05 date range47.6% physician / facility reported52.4% manufacturer reported1 SKU variants
Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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