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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- defective-component
- structural-failure
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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