Exactech AcuMatch XLE Hip Implants Recalled Due to Missing Protective Barrier Layer
Exactech recalled AcuMatch XLE hip implants due to the absence of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Approximately 42 units were distributed in the U.S. and internationally.
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 a Class II medical device recall for a hip replacement implant with a missing barrier layer. The rubric specifies Score 3 (High) for risk-of-harm medical devices where injury has not yet been reported; no illnesses or injuries are documented in the recall notice.
Plain-English summary
Exactech is recalling certain AcuMatch XLE hip replacement implant components due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Approximately 42 units have been distributed in 22 U.S. states and Puerto Rico, including Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, and Virginia.
Additional units were distributed internationally to Argentina, Colombia, Germany, Guatemala, Japan, and Spain.
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
- manufacturing-defect
- missing-barrier-layer
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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