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.

101–125 of 211

  • ModerateFDA (Devices)·Z-0307-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3020-2020·2020-10-07

    Exactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits

    Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.

    Product
    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-3019-2020·2020-10-07

    Exactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits

    Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kits because they may contain screws of incorrect length.

    Product
    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2926-2020·2020-09-09

    Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Error

    Exactech is recalling 11 Vantage Total Ankle Tibial Inserts because the labels incorrectly identify the implant size as 3 instead of 4.

    Product
    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1364-2020·2020-03-04

    Exactech Recalls Truliant Splined Stem Extensions Due to Labeling Error

    Exactech is recalling four Truliant Splined Stem Extensions because the labels incorrectly identify the implant size as 17mm x 80mm instead of 18mm x 120mm.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0873-2020·2020-02-05

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation

    Exactech is recalling Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.

    Product
    Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi-
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0872-2020·2020-02-05

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation

    Exactech is recalling 2,910 Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.

    Product
    Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- a
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0361-2020·2019-11-20

    Exactech Recalls Fluted Pin Pouches Due to Potential Quantity Error

    Exactech is recalling 2.4mm x 2.5 Fluted Pin Pouches because they may contain one pin instead of four. The recall covers 9 units distributed in four states.

    Product
    2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional tech
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2020·2019-10-30

    Exactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk

    Exactech, Inc. is recalling 158 Ergo 3.2mm K-wires because they may fracture at the threads and remain in the glenoid during shoulder surgery.

    Product
    Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2019·2019-09-18

    Exactech Recalls Threaded Offset Cup Impactor Due to Gritty Mechanism

    Exactech, Inc. is recalling 22 Threaded Offset Cup Impactors because the threaded mechanism may be gritty and difficult to turn, potentially due to entrapped blast media.

    Product
    Threaded Offset Cup Impactor - Product Usage: 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 transient
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1688-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.

    Product
    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1690-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech is recalling three units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to cold storage equipment failure.

    Product
    Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1689-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech, Inc. is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.

    Product
    Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1208-2019·2019-05-01

    Exactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement

    Exactech is recalling 18 Truliant Tibial Fit Trays because they were mismarked as size 3. The devices were distributed to facilities in 10 US states.

    Product
    Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0958-2019·2019-03-06

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Packaging Instructions

    Exactech is recalling 40 Equinoxe Preserve Humeral Stems because they may have been packaged with instructions for a different knee implant.

    Product
    Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplast
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2019·2018-10-10

    Exactech Equinoxe Reverse Drill Bit Kit Recalled for Incorrect Components

    Exactech is recalling Equinoxe Reverse Drill Bit Kits because they may contain two 2mm drill bits instead of the intended 2mm and 3.2mm combination.

    Product
    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3209-2018·2018-09-26

    Exactech Recalls Optetrak Logic CC Stem Extension Due to Thread Defects

    Exactech is recalling one unit of the Optetrak Logic CC Stem Extension because it may have non-conforming internal threads.

    Product
    Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic d
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2966-2018·2018-09-12

    Exactech Recalls Tibial Alignment Guides Due to Incorrect GTIN Labeling

    Exactech is recalling 7 Tibial Alignment Guides because the Global Trade Item Number (GTIN) printed on the devices is incorrect.

    Product
    Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0603-2018·2018-02-21

    Exactech Orthopedic Surgical Tool Recalled for Fracture Risk

    Exactech is recalling 41 GPS Total Shoulder Application 3.2mm Vix Bits because they may fracture during use.

    Product
    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0538-2018·2018-02-14

    Exactech Recalls Alteon HA Femoral Stems Due to Labeling Error

    Exactech is recalling 34 Alteon HA Femoral Stems because the labels incorrectly described the device. The units were distributed to five US states.

    Product
    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecros
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0414-2018·2018-02-07

    Exactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components

    Exactech is recalling 30 Equinoxe Cage, Glenoid, Alpha, Small components due to potential mislabeling. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.

    Product
    Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the pr
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0415-2018·2018-02-07

    Exactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling

    Exactech is recalling 30 Equinoxe shoulder implants because they may be mislabeled. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.

    Product
    Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the p
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0200-2018·2017-12-13

    Exactech Vantage Total Ankle Tibial Insert Recalled for Labeling Mismatch

    Exactech is recalling nine Vantage Total Ankle Tibial Inserts due to possible mismatches between inner and outer packaging labels.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where su
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0201-2018·2017-12-13

    Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch

    Exactech, Inc. is recalling nine Vantage Total Ankle Tibial Inserts because the inner labeling and packaged device may not match the outer box label.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where suffi
    Category
    Medical Device
    Distribution
    1 state

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.