Manufacturer

Exactech, Inc.

97 recalls in our database name Exactech, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–97 of 97

HighFDA (Devices)·Z-2127-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear
Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to risk of edge-loading and premature wear in certain patient configurations and surgical placements.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2021·2021-07-28
Exactech Connexion GXL hip implant liners risk edge-loading and wear
Exactech Connexion GXL acetabular polyethylene liners used in hip replacements may experience edge-loading and premature wear in certain patients due to implant configuration or surgical positioning. Approximately 89,050 units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2021·2021-07-28
Exactech Connexion GXL hip implant liners recalled due to premature wear risk
Exactech is recalling 89,050 Connexion GXL hip implant liners distributed nationwide due to a risk of edge-loading and premature wear in certain patient implant configurations.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2021·2021-07-28
Exactech Connexion GXL hip implant liners recalled for premature wear risk
Exactech is recalling 89,050 hip implant liners due to edge-loading and premature wear risk in a subset of patients with certain implant configurations.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Risk Premature Wear
Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2021·2021-07-28
Exactech Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain patient configurations. No injuries have been reported.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2112-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL hip implant liners are being recalled due to risk of edge-loading and premature wear in certain surgical configurations. Approximately 89,050 units distributed nationwide may be affected.
Product
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 Liner 5/15 DEG. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2021·2021-07-28
Hip implant polyethylene liners recalled due to premature wear risk
Exactech Connexion GXL acetabular liners used in hip implants are recalled due to risk of edge-loading and premature wear in patients with specific implant configurations and surgical positioning.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling certain acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in specific implant configurations and surgical positions.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2116-2021·2021-07-28
Hip Implant Acetabular Liners Recalled for Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in orthopedic hip implants are recalled due to risk of edge-loading and premature wear in certain configurations. The recall affects 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2021·2021-07-28
Hip implant acetabular liners recalled for edge-loading and premature wear
Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2114-2021·2021-07-28
Hip implant liners recalled due to risk of premature wear
Exactech is recalling 89,050 hip implant liners due to risk of edge-loading and premature wear in specific patient and surgical configurations affecting a subset of patients.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling Connexion GXL hip implant liners due to edge-loading and premature wear risk in certain patient configurations. The recall affects 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2124-2021·2021-07-28
Hip implant liners recalled for edge-loading and premature wear
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain configurations. About 89,050 units distributed nationwide are affected.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech recalls approximately 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in certain implant configurations.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2021·2021-07-28
Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems are recalled due to risk of edge-loading and premature wear in certain patients. The 89,050 affected units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to a risk of edge-loading and premature wear in certain implant configurations. No illnesses or injuries have been reported.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2122-2021·2021-07-28
Hip Implant Liners Recalled Due to Risk of Premature Wear
Exactech Connexion GXL hip implant liners are being recalled due to a risk of edge-loading and premature prosthesis wear in patients with certain implant configurations and surgical positioning.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2120-2021·2021-07-28
Exactech Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in hip implants face premature wear risk in certain patient and implant configurations. Consult your orthopedic surgeon if you have this device.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2021·2021-07-28
Exactech GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech is recalling its Connexion GXL acetabular polyethylene liners used in hip implants because they may experience edge-loading and premature wear in certain patient configurations and surgical positioning. A total of 89,050 units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1977-2021·2021-07-07
Exactech Humeral Augmented Tray orthopedic implant components recalled for disengagement risk
Exactech is recalling Humeral Augmented Tray (HAT) orthopedic implant components because the retaining ring may disengage during use. The recall affects 36 devices distributed in six U.S. states.
Product
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tr
Category
Medical Device
Distribution
Distributed nationwide