Exactech, Inc.
2320 N.W. 66TH CT., GAINESVILLE, FL, US
Registered product codes
63 product codes
Recent MDR events
22,418 on file
- HUMERAL ADAPTER TRAY, +15Jul 31, 2026Injury1038671-2026-00962
- 145-DEG PE 46MM HUM LINER +2.5Jul 31, 2026Injury1038671-2026-00963
- Equinoxe Reverse Shoulder ComponentsJul 30, 2026Injury1038671-2026-00961
- Unknown Metal ComponentJul 29, 2026Injury1038671-2026-00942
- Unknown Metal componentJul 29, 2026Injury1038671-2026-00945
- Unknown Metal ComponentJul 29, 2026Injury1038671-2026-00946
- TRULIANT CR POR FEM CR POR RIGHT SZ 3.5Jul 29, 2026Injury1038671-2026-00948
- LOGIC TIB INSERT IMPL CRC, SZ 3, 11MMJul 29, 2026Injury1038671-2026-00949
- RS GLENOID PLATE L POST AUG, 8 DEG, LEFTJul 29, 2026Injury1038671-2026-00954
- 145-DEG PE 38MM HUM LINER +0Jul 29, 2026Injury1038671-2026-00953
Recalls
221 on file
- Open, ClassifiedMar 9, 2026
Impactor handle may be missing cross-pin
View FDA record ↗ - Open, ClassifiedMar 9, 2026
Impactor handle may be missing cross-pin
View FDA record ↗ - Open, ClassifiedNov 17, 2025
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
View FDA record ↗ - Open, ClassifiedNov 17, 2025
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
View FDA record ↗ - Open, ClassifiedNov 17, 2025
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
View FDA record ↗ - Open, ClassifiedSep 12, 2025
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
View FDA record ↗ - Open, ClassifiedSep 12, 2025
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
View FDA record ↗ - Open, ClassifiedFeb 12, 2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
View FDA record ↗ - Open, ClassifiedFeb 12, 2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
View FDA record ↗ - Open, ClassifiedFeb 12, 2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
View FDA record ↗
Compliance history
Matched by FEI 1038671.
FDA inspections
3 on file
- Official Action Indicated (OAI)Aug 27, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Oct 9, 2024
Compliance: Devices
- Voluntary Action Indicated (VAI)Oct 9, 2024
Postmarket Assurance: Devices
Inspection citations
9 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(c)Design input - documentation
121 CFR 820.30(f)Design verification - output does not meet input requirement
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
121 CFR 820.75(a)Lack of or inadequate process validation
1
- 21 CFR 820.30(c)Aug 27, 2025
Design input - documentation
- 21 CFR 820.30(f)Aug 27, 2025
Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Aug 27, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Aug 27, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(b)Aug 27, 2025
Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(a)Aug 27, 2025
Lack of or inadequate process validation
- 21 CFR 820.75(c)Aug 27, 2025
Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Aug 27, 2025
Lack of or inadequate procedures
- 21 CFR 820.181Aug 27, 2025
DMR - not or inadequately maintained
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.