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Equinoxe®
Exactech, Inc.
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Exactech, Inc.
- Warning Letter 2025-12-19 Exactech Sarasota, Inc.
- Warning Letter 2024-01-19 Exactech, Inc.
- Warning Letter 2024-01-19 Exactech, Inc.
- OAI 2025-08-27 Exactech, Inc. · 9 citations
- OAI 2025-08-27 Exactech, Inc. · 9 citations
- OAI 2025-07-25 Exactech Sarasota, Inc. · 7 citations
- VAI 2024-10-09 Exactech, Inc. · 0 citations
- VAI 2024-10-09 Exactech, Inc. · 0 citations
- OAI 2023-09-26 Exactech, Inc. · 2 citations
- OAI 2023-09-26 Exactech, Inc. · 2 citations
- VAI 2021-11-17 Exactech, Inc. · 4 citations
- VAI 2021-11-17 Exactech, Inc. · 4 citations
- VAI 2020-01-31 Exactech, Inc. · 7 citations
- VAI 2020-01-31 Exactech, Inc. · 7 citations
- VAI 2017-03-10 Exactech, Inc. · 7 citations
- VAI 2017-03-10 Exactech, Inc. · 7 citations
- NAI 2015-07-16 Exactech, Inc. · 0 citations
- NAI 2015-07-16 Exactech, Inc. · 0 citations
- NAI 2014-08-25 Exactech Sarasota, Inc. · 0 citations
- NAI 2012-12-11 Exactech, Inc. · 0 citations
- NAI 2012-12-11 Exactech, Inc. · 0 citations
- VAI 2010-03-25 Exactech, Inc. · 0 citations
- VAI 2010-03-25 Exactech, Inc. · 0 citations