The Recall Desk

FDA (Devices) recall action 88126

Exactech, Inc. recalled 22 products on 2021-07-28

The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.

Products
22
Announced
2021-07-28
Critical
0
Units
1,959,100

Why these products were recalled

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–22 of 22

  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··2021-07-28

    Exactech GXL Acetabular Hip Implant Liners Recalled for Premature Wear Risk

    Exactech, Inc. is recalling 89,050 Connexion GXL and Novation GXL acetabular hip implant liners due to risk of edge-loading and premature prosthesis wear in certain patients. The risk depends on implant configuration and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states