Exactech, Inc.
149 recalls on record · Latest: Nov 26, 2025
FDA Devices Moderate Aug 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. O…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL …
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm;…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner,…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm …
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; N…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized,…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; an…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized,…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. O…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized,…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; an…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized,…
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL …
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and…
FDA Devices Moderate Jan 27, 2021
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
FDA Devices Moderate Nov 25, 2020
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Devices Moderate Nov 4, 2020
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
FDA Devices Moderate Oct 7, 2020
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Devices Moderate Oct 7, 2020
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Devices Moderate Sep 9, 2020
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
FDA Devices Moderate Mar 4, 2020
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femora…
FDA Devices Moderate Feb 5, 2020
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated …
FDA Devices Moderate Feb 5, 2020
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated f…
FDA Devices Moderate Jun 5, 2019
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
FDA Devices Moderate Jun 5, 2019
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
FDA Devices Moderate Jun 5, 2019
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
FDA Devices Moderate Mar 6, 2019
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degene…
FDA Devices Moderate Oct 10, 2018
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
FDA Devices Moderate Sep 26, 2018
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals under…
FDA Devices Moderate Sep 12, 2018
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
FDA Devices Moderate Dec 13, 2017
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheu…
FDA Devices Moderate Dec 13, 2017
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe r…
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
FDA Devices Moderate Nov 29, 2017