The Recall Desk

FDA (Devices) recall action 93507

Exactech, Inc. recalled 12 products on 2023-12-27

The FDA (Devices) publishes a recall like this one as 12 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 12 pages.

Products
12
Announced
2023-12-27
Critical
0
Units
—

Why these products were recalled

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

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

States named across these recalls

1–12 of 12

  • ModerateFDA (Devices)··2023-12-27

    Exactech knee replacement inserts recalled for vacuum seal loss

    Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.

    Product
    Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss

    Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.

    Product
    Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure

    Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.

    Product
    Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Vantage Ankle System Recalled Due to Vacuum Loss

    Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.

    Product
    Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    AcuMatch Hip System Recalled for Loss of Vacuum Integrity

    Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.

    Product
    AcuMatch Hip System, Catalog Number 142-32-27
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Equinoxe Shoulder System recalled for loss of vacuum

    Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.

    Product
    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
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Equinoxe Shoulder System recalled for vacuum loss in bags

    Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.

    Product
    Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Optetrak Logic PS Knee System Vacuum Loss Recall

    Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.

    Product
    Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Novation Hip System Recalled for Vacuum Seal Loss

    Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.

    Product
    Exactech Novation Hip System, Catalog Numbers: 134-36-45
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag

    Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.

    Product
    Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure

    Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.

    Product
    Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
    Category
    Distribution
    16 states
  • HighFDA (Devices)··2023-12-27

    Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure

    Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.

    Product
    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
    Category
    Distribution
    16 states