Exactech AcuMatch XLE Hip Implant Liner Recall
Exactech is recalling certain AcuMatch XLE hip implant liners due to a missing ethylene vinyl alcohol barrier layer. The missing barrier may affect the implant's performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. A missing critical structural component (EVOH barrier layer) on an implanted device used in major joint replacement surgery qualifies as Severe under the rubric, which designates FDA Class II recalls with significant risk potential as 4.
Plain-English summary
Exactech, Inc. is recalling certain AcuMatch XLE hip implant liners because they lack the ethylene vinyl alcohol (EVOH) barrier layer. This barrier is a component intended to protect the implant from fluid degradation.
The recalled product includes 42 different item numbers and configurations of AcuMatch XLE liners in various sizes. These are used in hip replacement surgery in skeletally mature individuals undergoing primary surgery for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip problems, or proximal femoral fracture treatment.
The recalled implants were distributed in the United States (Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, and Virginia) and internationally (Argentina, Colombia, Germany, Guatemala, Japan, and Spain).
Patients who have received one of these implants should contact their surgeon or Exactech for further guidance. Healthcare providers should verify product item numbers against the detailed UDI codes and item numbers listed in the recall notice.
The recalled product
- 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…
- Manufacturer
- Exactech, Inc.
- Affected units
- 42
Distribution
Part of a larger recall action
This product is one of 3 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModeratePilot tip converters recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- HighMedline Surgical Kits Recalled Due to Defective Smoke Evacuation Component
FDA (Devices) · 2024-12-11
- ModerateMedline Medical Convenience Kits Recall Due to Recalled Component
FDA (Devices) · 2024-12-11
Similar recalls
- HighHip implant polyethylene liners recalled due to premature wear risk
FDA (Devices) · 2021-07-28
- HighExactech Hip Implant Liners Recalled Due to Premature Wear Risk
FDA (Devices) · 2021-07-28
- HighGXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect
FDA (Devices) · 2022-09-21
- HighExactech GXL Hip Implant Liners Recalled for Premature Wear Risk
FDA (Devices) · 2021-07-28
- HighHip Implant Liners Recalled Due to Risk of Premature Wear
FDA (Devices) · 2021-07-28
- HighExactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
FDA (Devices) · 2021-07-28