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Exactech 170-40-93Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862155535), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 injury.

7 other recalls cover devices cleared under the same FDA submission (K121392); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bacterial Infection1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, THE FEMALE, MORBIDLY OBESE PATIENT HAD A REVISION RIGHT HIP SURGERY FOR RE-IMPLANTATION, POST-INFECTION, ON (B)(6) 2022. THE PATIENT WAS IMPLANTED WITH A COMPETITOR'S ACETABULAR COMPONENT AND AN EXACTECH HIP MONOBLOC STEM, ALONG WITH A CERAMIC FEMORAL HEAD. THE PATIENT PRESENTED BACK WITH A RE-INFECTION OF THE RIGHT HIP POST-REVISION SURGERY. THE PATIENT WAS SCHEDULED FOR A RIGHT HIP I&D AND EXPLANT OF HIP IMPLANTS ON (B)(6) 2023. ALL IMPLANTS, INCLUDING THE EXACTECH REVISION HIP STEM AND HEAD, WERE REMOVED AND AN ANTIBIOTIC SPACER HIP IMPLANT WAS IMPLANTED INTO THE PATIENT. THE PATIENT WILL BE MONITORED FOR INFECTION FOLLOW-UP. THERE IS NO REPORTED BREAKAGE OF DEVICES AND A 30-45 MINUTE SURGICAL DELAY/PROLONGATION AS THE PATIENT UNDERWENT EXTENSIVE IRRIGATION AND DEBRIDEMENT FOR INFECTION. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Bacterial Infection; Unspecified Infection

    MAUDE report 16492629 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121392. One submission often covers many models, so check the product and lot details in each record.

  • Z-1732-2022 · Aug 11, 2022 · Open, Classified
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL,
  • Z-2133-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
  • Z-2118-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
  • Z-2129-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant
  • Z-2123-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
  • Z-2117-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,
  • Z-2119-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component

Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices

All Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices →

Sources and updates

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