The Recall Desk

Manufacturer

Exactech, Inc.

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

What the numbers show

Total
211
Critical
0
Severe
14
Most recent
2026-03-18

Of the 211 recalls from Exactech, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (7%) are Severe.

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.

151–175 of 211

  • HighFDA (Devices)·Z-0127-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 109 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0138-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 527 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0131-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility

    Exactech, Inc. is recalling 640 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0128-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech, Inc. is recalling 114 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0129-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 198 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0133-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 801 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-3018-2017·2017-08-23

    Exactech Recalls Truliant Tibial Trial Handles Due to Pin Disassociation Risk

    Exactech is recalling 68 Truliant Tibial Trial Handles because the pin may disassociate from the main body. The devices were distributed to 11 states.

    Product
    Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibi
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2667-2017·2017-07-12

    Exactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming

    Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2668-2017·2017-07-12

    Exactech Equinoxe Reamer Recall Due to Updated Instructions for Use

    Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2664-2017·2017-07-12

    Exactech Equinoxe Glenoid Reamer Recalled for Updated Instructions

    Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2663-2017·2017-07-12

    Exactech Equinoxe Reverse Starter Reamer Recalled for Updated Instructions

    Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2666-2017·2017-07-12

    Exactech Equinoxe Modular Reverse Pilot-Tip Reamer Recall for Labeling Clarification

    Exactech is recalling Equinoxe Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2665-2017·2017-07-12

    Exactech Equinoxe Modular Reverse Pilot-Tip Starter Reamer Recall

    Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent instrument breakage.

    Product
    EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2662-2017·2017-07-12

    Exactech Recalls Logic Fit Tibial Tamp Heads for Labeling Clarification

    Exactech, Inc. is recalling 573 Logic Fit Tibial Tamp Heads to update surgical labeling. The update clarifies proper removal techniques to prevent instrument breakage.

    Product
    Logic Fit Tibial Tamp Head
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2644-2017·2017-07-05

    Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification

    Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.

    Product
    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2017·2017-01-25

    Exactech Recalls Alteon Neck Preserving Stems Due to Incorrect GTIN Labels

    Exactech is recalling 98 Alteon Neck Preserving Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs) that identify them as different devices.

    Product
    Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1030-2017·2017-01-25

    Exactech Recalls Novation Cemented Plus Femoral Stems Due to Labeling Error

    Exactech is recalling 79 Novation Cemented Plus Femoral Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs).

    Product
    Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1031-2017·2017-01-25

    Exactech Recalls Polyethylene Acetabular Liners Due to Incorrect GTIN Labels

    Exactech, Inc. is recalling 12 polyethylene acetabular liners because they were labeled with incorrect Global Trade Item Numbers (GTINs).

    Product
    AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0900-2017·2016-12-28

    Exactech Recalls Equinoxe Reverse Shoulder Screw Kits Due to Disengaged Heads

    Exactech, Inc. is recalling 2,278 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kits because disengaged screw heads may not be retained in the screwdriver.

    Product
    Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2128-2016·2016-07-13

    Exactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling

    Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.

    Product
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2127-2016·2016-07-13

    Exactech Recalls Hip Replacement Stems Due to Incorrect GTIN Labeling

    Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).

    Product
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonec
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

EXACTECH, INC.

Source: Wikidata (Q140158767), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.