AcuMatch XLE (Exactech) – Barrier Layer Missing (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 0LNR E 28MM 140-28-26 AM EHXL 0LNR F 28MM 140-28-28 AM EHXL 0LNR H 28MM 140-36-28 AM EHXL 0LNR H 36MM 140-28-30 AM EHXL 0LNR K 28MM 142-28-24 AM EHXL 15 LNR D 28MM 142-28-26 AM EHXL 15 L
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Exactech, Inc. is recalling AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 L due to Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Recommended Action
Per FDA guidance
On 12/31/2024, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter via FedEx to customers initially informing them that the firm was recalling specific hip polyethylene liner lots that were inadvertently packaged without the ethylene vinyl alcohol (EVOH) layer in the innermost bag. An updated customer notification letter was communicated to affected customer via email on 01/17/2025. Customers are instructed to: -Immediate Discontinuation: Immediately discontinue use of all affected products -Quarantine and Return: Segregate and quarantine affected products and arrange for their return to Exactech. The Recall Confirmation Form section of this communication provides product return instructions. Clinical Guidance: 1. Patient Monitoring: Surgeons should regularly monitor patients with affected devices for potential risks such as device wear, failure, component cracking or fracture, new or worsening pain, bone loss and/or swelling, as per the instructions for use. 2. Diagnostic Considerations: Diagnostic imaging, such as X-rays, may be considered if device failure is suspected. 3. Revision Considerations: Revision of well-functioning devices is not recommended for patients. 4. Resources: Healthcare providers and patients with questions can access educational resources on our website exac.com/recall-information and use the device serial look-up tool. Public Contact - 352-377-1140 or email matt.collins@exac.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, SC, TN, TX, VA, PR
Page updated: Jan 10, 2026