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.

201–211 of 211

  • HighFDA (Devices)·Z-2361-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2012·2012-09-12

    Exactech Recalls Optetrak Logic Tibial Inserts Due to Dimensional Defects

    Exactech is recalling 193 Optetrak Logic Posterior Stabilized Tibial Inserts because they were found to be out of dimensional specification.

    Product
    OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2012·2012-08-29

    Exactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility

    Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.

    Product
    OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals underg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2118-2012·2012-08-08

    Exactech Recalls Shoulder and Spine Devices Due to Labeling Error

    Exactech is recalling Equinoxe and Octane-C devices because labeling incorrectly states a ten-year shelf life for parts qualified for five years.

    Product
    Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2119-2012·2012-08-08

    Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.

    Product
    Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2116-2012·2012-08-08

    Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.

    Product
    Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2120-2012·2012-08-08

    Exactech Recalls Orthopedic Devices Due to Incorrect Shelf Life Labeling

    Exactech is recalling specific orthopedic implants because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.

    Product
    Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2117-2012·2012-08-08

    Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because labeling incorrectly states a ten-year shelf life instead of the qualified five-year limit.

    Product
    Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2115-2012·2012-08-08

    Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.

    Product
    Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2070-2012·2012-08-01

    Exactech Recalls Optetrak Knee Trays Due to Potential Mislabeled Components

    Exactech is recalling specific Optetrak knee replacement trays because they may be mislabeled. The recall covers 16 units distributed in the US and several international countries.

    Product
    Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2071-2012·2012-08-01

    Exactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components

    Exactech is recalling 12 Optetrak tibial trays because they have the potential to be mislabeled. The affected trays were distributed in the US and several international countries.

    Product
    Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing prim
    Category
    Medical Device
    Distribution
    4 states

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.