Recall Z-1165-2025— Exactech, Inc.

Name: FDA recall Z-1165-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-31

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2024-12-31. It names one FDA 510(k) clearance: K173583. Product: 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 EHXL 0¿LNR E 28MM 140-28-26 AM EHXL 0¿LNR F 28MM 140-28-28 AM EHXL 0¿LNR H 28MM 140-36-28 AM EHXL 0¿LNR H 36MM 140-28-30 AM EHXL 0¿LNR K 28MM 142-28-24 AM EHXL 15¿ LNR D 28MM 142-28-26 AM EHXL 15¿ LNR F 28MM 142-32-27 AM EHXL 15¿ LNR G 32MM 142-32-28 AM EHXL 15¿ LNR H 32MM 142-36-28 AM EHXL 15¿ LNR H 36MM 142-36-29 AM EHXL 15¿ LNR J 26MM 142-28-29 AM EHXL 15¿ LNR J 28MM 142-32-29 AM EHXL 15¿ LNR J 32MM 142-28-30 AM EHXL 15¿ LNR K 28MM 142-32-30 AM EHXL 15¿ LNR K 32MM 142-36-30 AM EHXL 15¿ LNR K 36MM 142-28-25 AM EHXL 15¿LNR E 28MM 142-28-27 AM EHXL 15¿LNR G 28MM 142-28-28 AM EHXL 15¿LNR H 28MM 144-28-28 AM EHXL EXT LNR H 28MM 144-28-29 AM EHXL EXT LNR J 28MM 144-28-25 AM EHXL EXTLNR E 28MM 144-28-26 AM EHXL EXTLNR F 28MM 144-28-27 AM EHXL EXTLNR G 28MM 144-28-30 AM EHXL EXTLNR K 28MM 148-28-26 AM EHXL LAT LNR F 28MM 148-28-27 AM EHXL LAT LNR G 28MM 148-36-28 AM EHXL LAT LNR H 36MM 148-36-29 AM EHXL LAT LNR J 36MM 148-28-30 AM EHXL LAT LNR K 28MM 148-36-30 AM EHXL LAT LNR K 36MM 148-28-25 AM EHXL LATLNR E 28MM 148-28-28 AM EHXL LATLNR H 28MM 148-28-29 AM EHXL LATLNR J 28MM 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 the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.. Reason: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-31
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K173583 — Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.·cleared 2018-03-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 EHXL 0¿LNR E 28MM 140-28-26 AM EHXL 0¿LNR F 28MM 140-28-28 AM EHXL 0¿LNR H 28MM 140-36-28 AM EHXL 0¿LNR H 36MM 140-28-30 AM EHXL 0¿LNR K 28MM 142-28-24 AM EHXL 15¿ LNR D 28MM 142-28-26 AM EHXL 15¿ LNR F 28MM 142-32-27 AM EHXL 15¿ LNR G 32MM 142-32-28 AM EHXL 15¿ LNR H 32MM 142-36-28 AM EHXL 15¿ LNR H 36MM 142-36-29 AM EHXL 15¿ LNR J 26MM 142-28-29 AM EHXL 15¿ LNR J 28MM 142-32-29 AM EHXL 15¿ LNR J 32MM 142-28-30 AM EHXL 15¿ LNR K 28MM 142-32-30 AM EHXL 15¿ LNR K 32MM 142-36-30 AM EHXL 15¿ LNR K 36MM 142-28-25 AM EHXL 15¿LNR E 28MM 142-28-27 AM EHXL 15¿LNR G 28MM 142-28-28 AM EHXL 15¿LNR H 28MM 144-28-28 AM EHXL EXT LNR H 28MM 144-28-29 AM EHXL EXT LNR J 28MM 144-28-25 AM EHXL EXTLNR E 28MM 144-28-26 AM EHXL EXTLNR F 28MM 144-28-27 AM EHXL EXTLNR G 28MM 144-28-30 AM EHXL EXTLNR K 28MM 148-28-26 AM EHXL LAT LNR F 28MM 148-28-27 AM EHXL LAT LNR G 28MM 148-36-28 AM EHXL LAT LNR H 36MM 148-36-29 AM EHXL LAT LNR J 36MM 148-28-30 AM EHXL LAT LNR K 28MM 148-36-30 AM EHXL LAT LNR K 36MM 148-28-25 AM EHXL LATLNR E 28MM 148-28-28 AM EHXL LATLNR H 28MM 148-28-29 AM EHXL LATLNR J 28MM 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 the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

Reason for recall

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.