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All Recalls

Every Exactech, Inc. Recall

Sorted by most recent. Click any recall for full details.

136 recalls
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Medical Implants·30 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Medical Implants·29 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 De...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Line...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Medical Devices·14 affected·Nov 9, 2020
High RiskFDA
Exactech, Inc.
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Medical Devices·69 affected·Oct 6, 2020
High RiskFDA
Exactech, Inc.
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Medical Devices·25 affected·Sep 25, 2020
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Medical Devices·149 affected·Aug 24, 2020
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Medical Devices·125 affected·Aug 24, 2020
High RiskFDA
Exactech, Inc.
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Medical Devices·11 affected·Aug 10, 2020
High RiskFDA
Exactech, Inc.
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which pro...
Medical Implants·4 affected·Jan 27, 2020
High RiskFDA
Exactech, Inc.
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System i...
Medical Devices·0 affected·Dec 3, 2019
High RiskFDA
Exactech, Inc.
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is...
Medical Devices·2,910 affected·Dec 3, 2019
High RiskFDA
Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Medical Devices·2 affected·Apr 26, 2019
High RiskFDA
Exactech, Inc.
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Medical Devices·3 affected·Apr 26, 2019
High RiskFDA
Exactech, Inc.
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Medical Devices·2 affected·Apr 26, 2019
High RiskFDA
Exactech, Inc.
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals...
Medical Implants·40 affected·Dec 5, 2018
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Medical Devices·2 affected·Aug 21, 2018
High RiskFDA
Exactech, Inc.
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Medical Devices·7 affected·Jul 13, 2018
High RiskFDA
Exactech, Inc.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature indiv...
Medical Devices·1 affected·May 8, 2018
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Medical Devices·643 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
Medical Devices·953 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Medical Devices·920 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
Medical Devices·306 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Medical Devices·665 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
Medical Devices·895 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
Medical Devices·311 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Medical Devices·333 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
Medical Devices·411 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
Medical Devices·575 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
Medical Devices·656 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
Medical Devices·520 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
Medical Devices·547 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
Medical Devices·678 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Medical Devices·640 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Medical Devices·733 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Medical Devices·527 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Medical Devices·198 affected·Sep 19, 2017