AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM E...
FDA Device Recall #Z-1165-2025 - Class II, December 31, 2024
Recall Summary
| Recall Number | Z-1165-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 31, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Exactech, Inc. |
| Location | Gainesville, FL |
| Product Type | Devices |
| Quantity | 42 |
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.
Distribution Pattern
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
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
Other Recalls from Exactech, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1509-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo M... | Feb 3, 2026 |
| Z-1510-2026 | Class II | Brand Name: Equinoxe Product Name: Equinoxe C... | Feb 3, 2026 |
| Z-0537-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo A... | Sep 5, 2025 |
| Z-0536-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjust... | Sep 5, 2025 |
| Z-0535-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjust... | Sep 5, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.