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.

176–200 of 211

  • ModerateFDA (Devices)·Z-1901-2016·2016-06-08

    Exactech Recalls Two Novation Ceramic Hip Acetabular Cups

    Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1905-2016·2016-06-08

    Exactech Recalls Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling nine Novation femoral stems because they were packaged before receiving FDA approval for a site change.

    Product
    Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1900-2016·2016-06-08

    Exactech Recalls Three Ceramic Hip Acetabular Cups Due to Premature Packaging

    Exactech is recalling three Novation Ceramic AHS Cluster-Hole Shells because they were packaged before the required site-change approval was granted.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1904-2016·2016-06-08

    Exactech Recalls One Novation Femoral Stem Device for Premature Packaging

    Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1902-2016·2016-06-08

    Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1903-2016·2016-06-08

    Exactech Recalls One Novation Femoral Stem for Premature Packaging

    Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0809-2016·2016-02-24

    Exactech Acapella One Interbody Fusion Device Packaging Labeling Recall

    Exactech is recalling 19 Acapella One Interbody Fusion Devices due to incorrect external and internal packaging labels.

    Product
    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at on
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0201-2016·2015-11-11

    Exactech Recalls Eight Hip Implant Stems Lacking Coating

    Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.

    Product
    Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2059-2015·2015-07-22

    Exactech Spine Set Screw Recalled for Incorrect Thread Form

    Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.

    Product
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2070-2015·2015-07-22

    Exactech Recalls Four Ambassador Cervical Plate Systems

    Exactech, Inc. is recalling four Ambassador Cervical Plate Systems that were shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by hist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2015·2015-07-22

    Exactech Single Barrel Drill Guides Recalled for Incomplete Final Inspection

    Exactech, Inc. is recalling two Single Barrel Drill Guides shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1459-2015·2015-04-29

    Exactech Recalls Equinoxe 44mm Short Humeral Head Shoulder Implants

    Exactech, Inc. is recalling 112 Equinoxe 44mm Short Humeral Head shoulder implant components because incorrect outer and inner labeling may misidentify the device size.

    Product
    Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0906-2015·2015-01-14

    Exactech Recalls Mislabeled Optetrak Femoral Implants

    Exactech, Inc. is voluntarily recalling 96 Optetrak femoral implants due to mislabeling. The devices were distributed internationally to 13 countries.

    Product
    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2086-2014·2014-07-30

    Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating

    Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.

    Product
    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1217-2014·2014-03-26

    Exactech Recalls Gibralt Spine System Polyaxial Screws Due to Material Error

    Exactech is recalling 242 Gibralt Spine System Polyaxial Screws because they contain springs made of type-304 stainless steel instead of the specified titanium alloy.

    Product
    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiogra
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0906-2014·2014-02-12

    Exactech Recalls InteGrip Acetabular Augments Due to Biological Evaluation Failure

    Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.

    Product
    ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1832-2013·2013-08-07

    Exactech Articulated Driver Recalled for Potential Disassembly During Use

    Exactech, Inc. is recalling 57 Articulated Driver units because the cross pin may shift out of position, potentially leading to instrument disassembly during orthopedic surgery.

    Product
    Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0953-2013·2013-03-27

    Exactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch

    Exactech is recalling 123 Optetrak Logic knee prosthesis spacers and screws because a dimensional mismatch could allow interference between devices.

    Product
    Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2013·2013-02-13

    Exactech Recalls Novation Crown Cup Hip Liners Due to Labeling Error

    Exactech is recalling 26 units of Novation Crown Cup hip replacement liners because device labeling was inadvertently transposed.

    Product
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0788-2013·2013-02-13

    Exactech Recalls Hip Replacement Liners Due to Labeling Error

    Exactech is recalling 26 hip replacement liners because the device labeling was inadvertently transposed. The units were distributed in five states.

    Product
    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2363-2012·2012-09-19

    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 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm 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-2362-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition

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

    Product
    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm 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-2364-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Sterility Issues

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

    Product
    REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***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-2366-2012·2012-09-19

    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 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm 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-2365-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues

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

    Product
    REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm 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

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.