Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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.
Why it was recalled
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
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
Recall record
- Recalling firm
- Exactech, Inc.
- Product type
- Devices
- Recall number
- Z-1165-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Gainesville, FL
- Recall initiated
- 2024-12-31
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1165-2025 · Source: openFDA enforcement.