Exactech AcuMatch XLE Hip Implants Recalled for Missing Barrier Layer
Exactech, Inc. is recalling AcuMatch XLE hip replacement components due to a missing Ethylene Vinyl Alcohol (EVOH) barrier layer. The recall affects 42 units distributed across multiple U.S. states and international locations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an orthopedic implant with a structural defect (missing EVOH barrier layer). No injuries or hospitalizations are reported in the source material. Per the severity rubric, risk-of-harm products with an implanted medical device defect where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Exactech, Inc. is recalling certain AcuMatch XLE hip implant components due to the absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer in the affected devices. The recall affects 42 units across multiple component models and sizes.
The affected components were distributed to healthcare facilities in 22 U.S. states and territories including 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. Devices were also distributed internationally to Argentina, Colombia, Germany, Guatemala, Japan, and Spain.
This FDA Class II recall addresses a structural defect in the devices caused by the missing EVOH barrier layer. Patients who have received these hip implants should contact their healthcare provider with questions about their specific device. Healthcare facilities should verify their inventory against the provided item numbers and UDI-DI codes to identify potentially affected devices.
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.
- Hazard
- missing-barrier-layer
- device-defect
Distribution
Distributed in 22 states:
- AR
- CA
- CO
- FL
- GA
- HI
- IL
- IN
- KS
- KY
- LA
- MD
- MN
- NV
- NY
- OH
- OK
- PR
- SC
- TN
- TX
- VA
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