99 results
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24ms
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Sources: EU EUDAMED, US FDA
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·August 15, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·August 15, 2025
AcuMatch Hip System, Catalog Number 142-32-27
FDA Recall
Open, Classified
·Exactech, Inc.·Product code OQI·November 21, 2023
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·March 6, 2024
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024
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 Liner 5/15 DEG. Orthopedic hip implant component.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code LPH·June 29, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code LPH·June 29, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWZ·August 11, 2022
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-29 AM EHXL 0 LNR J 32MM 140-36-29 AM EHXL 0 LNR J 36MM 140-32-30 AM EHXL 0 LNR K 32MM 140-36-30 AM EHXL 0 LNR K 36MM 140-28-25 AM EHXL 0LNR E 28MM 140-28-26 AM EHXL 0LNR F 28MM 140-28-28 AM EHXL 0LNR H 28MM 140-36-28 AM EHXL 0LNR H 36MM 140-28-30 AM EHXL 0LNR K 28MM 142-28-24 AM EHXL 15 LNR D 28MM 142-28-26 AM EHXL 15 LNR F 28MM 142-32-27 AM EHXL 15 LNR G 32MM 142-32-28 AM EHXL 15 LNR H 32MM 142-36-28 AM EHXL 15 LNR H 36MM 142-36-29 AM EHXL 15 LNR J 26MM 142-28-29 AM EHXL 15 LNR J 28MM 142-32-29 AM EHXL 15 LNR J 32MM 142-28-30 AM EHXL 15 LNR K 28MM 142-32-30 AM EHXL 15 LNR K 32MM 142-36-30 AM EHXL 15 LNR K 36MM 142-28-25 AM EHXL 15LNR E 28MM 142-28-27 AM EHXL 15LNR G 28MM 142-28-28 AM EHXL 15LNR H 28MM 144-28-28 AM EHXL EXT LNR H 28MM 144-28-29 AM EHXL EXT LNR J 28MM 144-28-25 AM EHXL EXTLNR E 28MM 144-28-26 AM EHXL EXTLNR F 28MM 144-28-27 AM EHXL EXTLNR G 28MM 144-28-30 AM EHXL EXTLNR K 28MM 148-28-26 AM EHXL LAT LNR F 28MM 148-28-27 AM EHXL LAT LNR G 28MM 148-36-28 AM EHXL LAT LNR H 36MM 148-36-29 AM EHXL LAT LNR J 36MM 148-28-30 AM EHXL LAT LNR K 28MM 148-36-30 AM EHXL LAT LNR K 36MM 148-28-25 AM EHXL LATLNR E 28MM 148-28-28 AM EHXL LATLNR H 28MM 148-28-29 AM EHXL LATLNR J 28MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code OQI·December 31, 2024
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·September 5, 2025
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·November 21, 2023
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·November 21, 2023
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·January 27, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·March 6, 2024
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·March 6, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code PHX·March 6, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024