FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

EXACTECH, INC.

EXACTECH, INC. is an FDA-registered device establishment (FEI 1038671) located in GAINESVILLE, Florida. The facility is active, registered. Its most recent FDA inspection on record (2025-08-27) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Jan 19, 2024
CGMP/QSR/Medical Devices/Adulterated
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (8)

Feb 3, 2026 Class II
Impactor handle may be missing cross-pin
OngoingView source data ›
Aug 15, 2025 Class II
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
OngoingView source data ›
Dec 31, 2024 Class II
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
OngoingView source data ›
Mar 6, 2024 Class II
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
OngoingView source data ›
Aug 11, 2022 Class II
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
OngoingView source data ›
Aug 30, 2021 Class II
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
OngoingView source data ›
Jun 29, 2021 Class II
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
OngoingView source data ›
Jun 29, 2021 Class II
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
CompletedView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
1038671
Address
2320 N.W. 66TH CT., GAINESVILLE, Florida
Establishment type
Device establishment
Products / operations
Orthopedic, Manufacture Medical Device, General, Plastic Surgery, Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility, Unknown, Manufacture Device in the United States for Export Only, Dental
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Aug 27, 2025 · Official Action Indicated (OAI)
Oct 9, 2024 · Voluntary Action Indicated (VAI)
Sep 26, 2023 · Official Action Indicated (OAI)
Nov 17, 2021 · Voluntary Action Indicated (VAI)
Jan 31, 2020 · Voluntary Action Indicated (VAI)
Jan 31, 2020 · No Action Indicated (NAI)
Jul 21, 2017 · No Action Indicated (NAI)
Mar 10, 2017 · Voluntary Action Indicated (VAI)
Jul 16, 2015 · No Action Indicated (NAI)
Jul 24, 2014 · No Action Indicated (NAI)
Dec 11, 2012 · No Action Indicated (NAI)
May 18, 2012 · No Action Indicated (NAI)
Form 483 observations
Aug 27, 2025, 9 observations: Process changes - review, evaluation and revalidation; Lack of or inadequate procedures; Design Validation - Risk analysis not performed/inadequate
Sep 26, 2023, 2 observations: Report of Death or Serious Injury; Lack of or inadequate procedures
Nov 17, 2021, 4 observations: Incorrect translation to production specifications; Sampling plans; Lack of or inadequate receiving acceptance procedures
Jan 31, 2020, 7 observations: Design validation- Lack of or inadequate procedures; Nonconforming product, Lack of or inadequate procedures; Lack of or inadequate procedures
Mar 10, 2017, 7 observations: Lack of or inadequate complaint procedures; Purchasing controls, Lack of or inadequate procedures; Design Validation - Risk analysis not performed/inadequate

FDA record timeline

Recall
Class II — Impactor handle may be missing cross-pin
Source ›
FDA inspection
OAI classification
Form 483
9 observations
Recall
Class II — Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Source ›
Recall
Class II — Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Source ›
FDA inspection
VAI classification
Recall
Class II — 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
Source ›
Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
OAI classification
Form 483
2 observations
Recall
Class II — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Source ›
FDA inspection
VAI classification
Form 483
4 observations
Recall
Class II — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Source ›
Recall
Class II — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Source ›
Recall
Class II — Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
Source ›

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is EXACTECH, INC. registered with the FDA?

Yes. EXACTECH, INC. is an FDA-registered device establishment (FEI 1038671) in GAINESVILLE, Florida. Its current registration status is Active, Registered.

Has EXACTECH, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to EXACTECH, INC.; the most recent is dated Jan 19, 2024 (CGMP/QSR/Medical Devices/Adulterated).

What does EXACTECH, INC. do?

EXACTECH, INC.'s FDA-registered operations are: Orthopedic, Manufacture Medical Device, General, Plastic Surgery, Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility, Unknown, Manufacture Device in the United States for Export Only, Dental.

Related facilities

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Source: FDA public data · status as of 2026-08-22

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