Exactech, Inc.

FDA recalling firm · 61 enforcement events · 211 product records · 2009–2026 · FL

Exactech, Inc. has 61 FDA enforcement events on this register (211 product records) between 2009 and 2026: 61 device; the busiest year was 2017 with 10.

0% of its events are Class I; the most common class is Class II (61). 17 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
3 Feb 2026	Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05	Device	Class II	2	Ongoing
5 Sep 2025	Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component	Device	Class II	3	Ongoing
15 Aug 2025	Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/	Device	Class II	2	Ongoing
31 Dec 2024	AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM 140-36-30 AM EHXL 0¿ LNR K 36MM 140-28-25 AM…	Device	Class II	3	Ongoing
26 Apr 2024	Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T	Device	Class II	1	Ongoing
18 Apr 2024	OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;	Device	Class II	4	Ongoing
6 Mar 2024	Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty	Device	Class II	24	Ongoing
21 Nov 2023	AcuMatch Hip System, Catalog Number 142-32-27	Device	Class II	12	Ongoing
5 Jun 2023	Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.	Device	Class II	2	Ongoing
11 Aug 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H…	Device	Class II	10	Ongoing
30 Aug 2021	OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX,…	Device	Class II	9	Ongoing
29 Jun 2021	Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.	Device	Class II	2	Completed
29 Jun 2021	Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.	Device	Class II	22	Ongoing
11 May 2021	Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT…	Device	Class II	1	Completed
9 Nov 2020	Equinoxe Humeral Stem, Primary, Press Fit, 11mm	Device	Class II	1	Ongoing
6 Oct 2020	Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium	Device	Class II	2	Terminated
25 Sep 2020	Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.	Device	Class II	2	Terminated
24 Aug 2020	Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.	Device	Class II	2	Terminated
10 Aug 2020	The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.	Device	Class II	1	Ongoing
27 Jan 2020	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.	Device	Class II	1	Ongoing
3 Dec 2019	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- arthroplasty is determined by the…	Device	Class II	2	Terminated
2 Oct 2019	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 technique for total ankle replacement.…	Device	Class II	1	Terminated
10 Sep 2019	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.	Device	Class II	1	Terminated
24 Jul 2019	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 use.	Device	Class II	1	Terminated
26 Apr 2019	Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30	Device	Class II	3	Terminated
13 Mar 2019	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 primary surgery for total knee replacement…	Device	Class II	1	Terminated
5 Dec 2018	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 arthroplasty is determined by the surgeon to be the…	Device	Class II	1	Terminated
21 Aug 2018	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery	Device	Class II	1	Ongoing
13 Jul 2018	Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.	Device	Class II	1	Terminated
8 May 2018	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 degenerative problems.	Device	Class II	1	Ongoing
9 Oct 2017	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, osteonecrosis, post-traumatic degenerative problems of…	Device	Class II	1	Terminated
19 Sep 2017	Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.	Device	Class II	34	Terminated
31 Aug 2017	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 preferred method of treatment.	Device	Class II	2	Terminated
11 Jul 2017	Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool	Device	Class II	1	Terminated
23 Jun 2017	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 Tibial Trial Handle	Device	Class II	1	Terminated
25 May 2017	Logic Fit Tibial Tamp Head	Device	Class II	1	Terminated
25 May 2017	EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01	Device	Class II	6	Terminated
22 May 2017	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 transient use. ech 1.5" Novation Calcar Planer…	Device	Class II	1	Terminated
16 May 2017	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 sufficient bone stock and soft tissue…	Device	Class II	2	Terminated
7 Apr 2017	Exactech Optetrak Logic CC 15mm Tibial Augment Screws	Device	Class II	1	Terminated
7 Nov 2016	Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.	Device	Class II	3	Terminated
25 Oct 2016	Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit	Device	Class II	1	Terminated
26 May 2016	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, osteonecrosis, post-traumatic degenerative…	Device	Class II	2	Terminated
12 Apr 2016	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.	Device	Class II	6	Terminated
28 Sep 2015	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 one disc level from C2-T1. Is to be used with…	Device	Class II	1	Terminated
23 Sep 2015	Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation	Device	Class II	1	Terminated
21 May 2015	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 history and radiographic studies),…	Device	Class II	2	Terminated
13 Feb 2015	Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.	Device	Class II	1	Terminated
9 Oct 2014	Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants	Device	Class II	1	Terminated
7 Mar 2014	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.	Device	Class II	1	Terminated
6 Jan 2014	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 radiographic studies), spondylolisthesis, spinal…	Device	Class II	1	Terminated
11 Sep 2013	*REF 186-01-08InteGrip ACETABULAR AUGMENTSMALL 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 replacement and whose orthopedic surgeon…	Device	Class II	1	Terminated
30 May 2013	Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.	Device	Class II	1	Terminated
1 Feb 2013	Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.	Device	Class II	1	Terminated
5 Nov 2012	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.	Device	Class II	2	Terminated
15 Jun 2012	Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty	Device	Class II	6	Terminated
24 Jan 2012	REF 101-05-20*NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mmUse with 20mm ScrewSTERILEEXACTECH 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 for hemi & total hip arthroplasty.…	Device	Class II	6	Terminated
17 Oct 2011	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 undergoing primary surgery for total knee…	Device	Class II	1	Terminated
23 Sep 2011	Product is labeled in part: "*OPTETRAKTIBIAL TRAYTRAPEZOID CEMENTEDTi Alloy SIZE 1F/1T, 2F/1TFOR CEMENTED USE ONLYExactech, Gainesville, FL 32653-1630.REF 204-04-21**". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for…	Device	Class II	2	Terminated
19 Aug 2011	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 Logic Total Knee System is indicated for use in…	Device	Class II	1	Terminated
6 Mar 2009	Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.	Device	Class II	1	Terminated

By type and class

Device61

Class II61

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Exactech, Inc. by year initiated.

Questions and answers

How many FDA recalls has Exactech, Inc. had?

61 enforcement events (211 product records) on this register, 2009–2026: 61 device.

Are any Exactech, Inc. recalls ongoing?

17 events are listed as ongoing in the current openFDA export.

What class are Exactech, Inc. recalls?

61 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.