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Exactech, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000017730 FEI 1038671

Exactech, Inc. is a medical device manufacturer based in the United States, with 13,661 devices listed and 221 FDA recalls as of 13 Nov 2026.

Devices
13,661
Registrations
EUDAMEDFDA
FDA recalls
22194 ongoing since 2021 (99 open in total)
5 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 2,912
  • EUDAMED 94
  • FDA 510(k) 4

Among the 3,000 best-ranked of 13,661 devices.

Device classes
  • FDA Class II 2,069
  • FDA Class I 839
  • EU Class III 88
  • FDA Class III 4

Among the 3,000 best-ranked of 13,661 devices.

Top EMDN categories

Among the 3,000 best-ranked of 13,661 devices.

FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000017730
  • FDA FEI 1038671
  • DUNS 157565946

At a glance

Counted by deviCERTS from registry records

EU certificates

5 of 5 in force.

See certificates

Market reach

European Union
EUDAMED actor, 5 certificates
United States
FDA FEI, FDA recalls

What Exactech, Inc. makes

Exactech, Inc. manufactures orthopaedic implants and surgical instruments, including tibial inserts, knee and ankle prostheses (both trial and fixed-bearing), acetabular shells, and non-bioabsorbable orthopaedic bone screws. Their reusable trial components for knee and tibia prostheses, as well as instrument trays, support preoperative planning and intraoperative procedures. Fixed-bearing total ankle prostheses and acetabular shells are designed for primary and revision joint replacements.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under the U.S. Food and Drug Administration’s medical device rules, with compliance required for market distribution in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13,661

Newest first, rows 1-50 of 13,661

Search and filter all 13,661 devices
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  • Vantage® Total Ankle Ref 350-42-22

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-02-05E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-01-05E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-15

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-13

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-13

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-23

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-03

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-34

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-31-04

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-24

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-61

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-33

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-42

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-12

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-02-03E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-01-04E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-32

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-34

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-04

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-54

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-02

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-05

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-01

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-63

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-01

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-45

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-14

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-21

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-02-04E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-44

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-53

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-04

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-62

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-25

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-65

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-31-03

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-11

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-21

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-31

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-62

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-22

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-25

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-01-02E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-11

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-52

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-54

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-61

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-41-35

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vantage® Total Ankle Ref 350-42-35

    Active Regimes: CE MDR Registry: EUDAMED Class:III

Rows 1-50 of 13,661

Showing 1-50 of 13,661

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000017730
FDA FEI number
1038671
DUNS number
157565946
EU VAT number
FR84483535712
EUDAMED status
Active
EUDAMED registered name
Exactech, Inc.
EUDAMED abbreviated name
Exac
Registered address
2320, NW 66th Court, 32653-1630, Gainesville, United States
Phone
(352) 377-1140
PRRC contact
Christine Thomas(public in EUDAMED)

EUDAMED certificates5

5 certificates5 valid, 0 expiredMDR 5next expiry 10 Dec 2028

EUDAMED certificates (5)

BSI Group The Netherlands B.V. 2797 3 certificates

  • MDR 777490 Active

    Technical documentation EU MDR

    Issued
    3 Sep 2026
    Expires
    2 Sep 2031
  • MDR 761535 Active

    Technical documentation EU MDR

    Issued
    18 Jun 2026
    Expires
    17 Jun 2031
  • MDR 760037 Active Supplemented

    Quality management system EU MDR

    Issued
    3 Sep 2026
    Expires
    10 Dec 2028
    Reason
    Add device or group

GMED SAS 0459 2 certificates

  • 40480 Active Amended

    Quality management system EU MDR

    Issued
    8 Sep 2026
    Expires
    15 Apr 2031
    Reason
    Mnf data change
  • 39968 Active Amended

    Quality management system EU MDR

    Issued
    8 Sep 2026
    Expires
    29 Aug 2029
    Reason
    Mnf data change

FDA recalls221

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 221 recalls initiated by Exactech, Inc., the earliest on 2003-06-17 and the most recent on 2026-02-03. By recorded status: 99 ongoing, 119 terminated and 3 with another status. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 50
  • 2018 4
  • 2019 9
  • 2020 9
  • 2021 34
  • 2022 10
  • 2023 14
  • 2024 32
  • 2025 5
  • 2026 2

52 initiated before 2017

Showing the 10 most recent of 221 recalls.

  • 2026

    • 3 Feb 2026 Z-1509-2026 Class II Ongoing Impactor handle may be missing cross-pin Distribution: US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan…
      Full distribution text US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
    • 3 Feb 2026 Z-1510-2026 Class II Ongoing Impactor handle may be missing cross-pin Distribution: US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan…
      Full distribution text US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia

  • 2025

    • 5 Sep 2025 Z-0535-2026 Class II Ongoing Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. Distribution: U.S.: SC O.U.S.: N/A Submission number: K042021
    • 5 Sep 2025 Z-0536-2026 Class II Ongoing Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. Distribution: U.S.: SC O.U.S.: N/A Submission number: K042021
    • 5 Sep 2025 Z-0537-2026 Class II Ongoing Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. Distribution: U.S.: SC O.U.S.: N/A Submission number: K042021
    • 15 Aug 2025 Z-2561-2025 Class II Ongoing Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV,…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.
      Submission number: K063569
    • 15 Aug 2025 Z-2562-2025 Class II Ongoing Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV,…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.
      Submission number: K223833

  • 2024

    • 31 Dec 2024 Z-1165-2025 Class II Ongoing Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina,…
      Full distribution text U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain
      Submission number: K173583
    • 31 Dec 2024 Z-1166-2025 Class II Ongoing Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina,…
      Full distribution text U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain
      Submission number: K173583
    • 31 Dec 2024 Z-1167-2025 Class II Ongoing Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina,…
      Full distribution text U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain
      Submission number: K182502
Show the 25 most recent of 221 recalls

  • 2024

    • 26 Apr 2024 Z-2236-2024 Class II Ongoing The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH. Distribution: Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan. Submission number: K013211
    • 18 Apr 2024 Z-2155-2024 Class II Ongoing Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Distribution: Worldwide distribution. Submission numbers: K160484, K932690, K933610
    • 18 Apr 2024 Z-2156-2024 Class II Ongoing Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Distribution: Worldwide distribution. Submission numbers: K160484, K932690, K933610
    • 18 Apr 2024 Z-2157-2024 Class II Ongoing Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Distribution: Worldwide distribution. Submission numbers: K160484, K932690, K933610
    • 18 Apr 2024 Z-2158-2024 Class II Ongoing Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Distribution: Worldwide distribution. Submission numbers: K160484, K932690, K933610
    • 6 Mar 2024 Z-1402-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K042021
    • 6 Mar 2024 Z-1403-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K042021
    • 6 Mar 2024 Z-1404-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K042021
    • 6 Mar 2024 Z-1405-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission numbers: K042021, K093430
    • 6 Mar 2024 Z-1406-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K103419
    • 6 Mar 2024 Z-1407-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K103419
    • 6 Mar 2024 Z-1408-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K111379
    • 6 Mar 2024 Z-1409-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K111379
    • 6 Mar 2024 Z-1410-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K121220
    • 6 Mar 2024 Z-1411-2024 Class II Ongoing The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain,…
      Full distribution text Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
      Submission number: K121220

Frequently asked questions

How many devices does Exactech, Inc. have in the registry?

The registry currently lists 13661 devices for Exactech, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Exactech, Inc.'s devices?

Among its 50 most recently registered devices, Exactech, Inc. has devices listed in EUDAMED (50 devices).

What risk classes do Exactech, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Exactech, Inc.'s devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Exactech, Inc.?

FDA recall records list 221 recalls initiated by Exactech, Inc., the most recent initiated on 3 Feb 2026. 99 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Exactech, Inc.?

EUDAMED lists 5 certificates for Exactech, Inc. (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 8 Sep 2026.

What are the newest devices from Exactech, Inc. in the registry?

The most recently registered devices listed for Exactech, Inc. include Vantage® Total Ankle.

Generated automatically from registry data and not verified by a human reviewer.