CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report

140-28-27 Am Ehxl 0¿ Lnr G 140-32-27 Am Ehxl 0¿ Lnr recalled

Exactech is recalling 140-28-27 Am Ehxl 0¿ Lnr G 140-32-27 Am Ehxl 0¿ Lnr G 140-32-28 Am Ehxl 0¿ Lnr H, distributed in 22 states. The recall was initiated on 31 Dec 2024 and the FDA has classified it as Class II.

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Lot, batch or date codesItem Number / Product Description/ UDI-DI code: 140-28-27 AM EHXL 0¿ LNR G 28MM 10885862537997 140-32-27 AM EHXL 0¿ LNR G 32MM 10885862538031 140-32-28 AM EHXL 0¿ LNR H 32MM 10885862538048 140-28-29 AM EHXL 0¿ LNR J 28MM 10885862538017 140-32-29 AM EHXL 0¿ LNR J 32MM 10885862538055 140-36-29 AM EHXL 0¿ LNR J 36MM 10885862538086 140-32-30 AM EHXL 0¿ LNR K 32MM 10885862538062 140-36-30 AM EHXL 0¿ LNR K 36MM 10885862538093 140-28-25 AM EHXL 0¿LNR E 28MM 10885862537973 140-28-26 AM EHXL 0¿LNR F 28MM 10885862537980 140-28-28 AM EHXL 0¿LNR H 28MM 10885862538000 140-36-28 AM EHXL 0¿LNR H 36MM 10885862538079 140-28-30 AM EHXL 0¿LNR K 28MM 10885862538024 142-28-24 AM EHXL 15¿ LNR D 28MM 10885862538123 142-28-26 AM EHXL 15¿ LNR F 28MM 10885862538147 142-32-27 AM EHXL 15¿ LNR G 32MM 10885862538192 142-32-28 AM EHXL 15¿ LNR H 32MM 10885862538208 142-36-28 AM EHXL 15¿ LNR H 36MM 10885862538239 142-36-29 AM EHXL 15¿ LNR J 26MM 10885862538246 142-28-29 AM EHXL 15¿ LNR J 28MM 10885862538178 142-32-29 AM EHXL 15¿ LNR J 32MM 10885862538215 142-28-30 AM EHXL 15¿ LNR K 28MM 10885862538185 142-32-30 AM EHXL 15¿ LNR K 32MM 10885862538222 142-36-30 AM EHXL 15¿ LNR K 36MM 10885862538253 142-28-25 AM EHXL 15¿LNR E 28MM 10885862538130 142-28-27 AM EHXL 15¿LNR G 28MM 10885862538154 142-28-28 AM EHXL 15¿LNR H 28MM 10885862538161 144-28-28 AM EHXL EXT LNR H 28MM 10885862538291 144-28-29 AM EHXL EXT LNR J 28MM 10885862538307 144-28-25 AM EHXL EXTLNR E 28MM 10885862538260 144-28-26 AM EHXL EXTLNR F 28MM 10885862538277 144-28-27 AM EHXL EXTLNR G 28MM 10885862538284 144-28-30 AM EHXL EXTLNR K 28MM 10885862538314 148-28-26 AM EHXL LAT LNR F 28MM 10885862538338 148-28-27 AM EHXL LAT LNR G 28MM 10885862538345 148-36-28 AM EHXL LAT LNR H 36MM 10885862538383 148-36-29 AM EHXL LAT LNR J 36MM 10885862538390 148-28-30 AM EHXL LAT LNR K 28MM 10885862538376 148-36-30 AM EHXL LAT LNR K 36MM 10885862538406 148-28-25 AM EHXL LATLNR E 28MM 10885862538321 148-28-28 AM EHXL LATLNR H 28MM 10885862538352 148-28-29 AM EHXL LATLNR J 28MM 10885862538369

Quantity recalled42

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1165-2025
FDA event ID: 96102
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 31 Dec 2024
FDA classified: 12 Feb 2025
Reported: 19 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

31 Dec 2024	Recall initiated by company
12 Feb 2025	Classified by FDA	+43 days
19 Feb 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Arkansas California Colorado Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Maryland Minnesota Nevada New York Ohio Oklahoma Puerto Rico South Carolina Tennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Item Number / Product Description/ UDI-DI code: 140-28-27 AM EHXL 0¿ LNR G 28MM 10885862537997 140-32-27 AM EHXL 0¿ LNR G 32MM 10885862538031 140-32-28 AM EHXL 0¿ LNR H 32MM 10885862538048 140-28-29 AM EHXL 0¿ LNR J 28MM 10885862538017 140-32-29 AM EHXL 0¿ LNR J 32MM 10885862538055 140-36-29 AM EHXL 0¿ LNR J 36MM 10885862538086 140-32-30 AM EHXL 0¿ LNR K 32MM 10885862538062 140-36-30 AM EHXL 0¿ LNR K 36MM 10885862538093 140-28-25 AM EHXL 0¿LNR E 28MM 10885862537973 140-28-26 AM EHXL 0¿LNR F 28MM 10885862537980 140-28-28 AM EHXL 0¿LNR H 28MM 10885862538000 140-36-28 AM EHXL 0¿LNR H 36MM 10885862538079 140-28-30 AM EHXL 0¿LNR K 28MM 10885862538024 142-28-24 AM EHXL 15¿ LNR D 28MM 10885862538123 142-28-26 AM EHXL 15¿ LNR F 28MM 10885862538147 142-32-27 AM EHXL 15¿ LNR G 32MM 10885862538192 142-32-28 AM EHXL 15¿ LNR H 32MM 10885862538208 142-36-28 AM EHXL 15¿ LNR H 36MM 10885862538239 142-36-29 AM EHXL 15¿ LNR J 26MM 10885862538246 142-28-29 AM EHXL 15¿ LNR J 28MM 10885862538178 142-32-29 AM EHXL 15¿ LNR J 32MM 10885862538215 142-28-30 AM EHXL 15¿ LNR K 28MM 10885862538185 142-32-30 AM EHXL 15¿ LNR K 32MM 10885862538222 142-36-30 AM EHXL 15¿ LNR K 36MM 10885862538253 142-28-25 AM EHXL 15¿LNR E 28MM 10885862538130 142-28-27 AM EHXL 15¿LNR G 28MM 10885862538154 142-28-28 AM EHXL 15¿LNR H 28MM 10885862538161 144-28-28 AM EHXL EXT LNR H 28MM 10885862538291 144-28-29 AM EHXL EXT LNR J 28MM 10885862538307 144-28-25 AM EHXL EXTLNR E 28MM 10885862538260 144-28-26 AM EHXL EXTLNR F 28MM 10885862538277 144-28-27 AM EHXL EXTLNR G 28MM 10885862538284 144-28-30 AM EHXL EXTLNR K 28MM 10885862538314 148-28-26 AM EHXL LAT LNR F 28MM 10885862538338 148-28-27 AM EHXL LAT LNR G 28MM 10885862538345 148-36-28 AM EHXL LAT LNR H 36MM 10885862538383 148-36-29 AM EHXL LAT LNR J 36MM 10885862538390 148-28-30 AM EHXL LAT LNR K 28MM 10885862538376 148-36-30 AM EHXL LAT LNR K 36MM 10885862538406 148-28-25 AM EHXL LATLNR E 28MM 10885862538321 148-28-28 AM EHXL LATLNR H 28MM 10885862538352 148-28-29 AM EHXL LATLNR J 28MM 10885862538369

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 96102

Reported	Class	Recall	Company	Reason	Where
19 Feb 2025	CLASS II	140-22-70 Nv Ehxl Ntl Lnr G00 140-28-50 Nv Ehxlntrl Lnr G0 recalled	Exactech	Other	22 states
19 Feb 2025	CLASS II	140-22-70 Nv Ehxl Ntl Lnr G00 140-28-50 Nv Ehxlntrl Lnr G0 recalled	Exactech	Other	22 states

More recalls from Exactech

All 197

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	Equinoxe Core Instrument Kit recalled by Exactech	Exactech	Other	19 states
18 Mar 2026Device	CLASS II	Equinoxe Ergo Modular Impactor Handle recalled by Exactech	Exactech	Other	19 states
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Augments Pilot Tip Converter recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC

Other Hip & Knee Implants recalls

All 3,110

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide