Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer
Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.
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 a surgical implant with a documented manufacturing defect (missing barrier layer). While no injuries are reported in the source, hip implants are high-risk devices, and a missing barrier component represents a structural defect that could affect device performance and longevity, requiring potential revision surgery.
Plain-English summary
Exactech, Inc. is recalling Alteon XLE hip replacement liners in multiple sizes and configurations due to a manufacturing defect. The liners lack the Ethylene Vinyl Alcohol (EVOH) barrier layer that is necessary for the devices to function as intended.
The affected liners are used in hip replacement surgery for patients with osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic hip problems, and proximal femoral fractures. The recalled devices include neutral liners, lip liners, lateral liners, 10-degree liners, and extended coverage liners in various sizes (22mm through 40mm).
The recall affects 1,446 liners distributed across multiple U.S. states (AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA) and internationally (Argentina, Colombia, Germany, Guatemala, Japan, Spain). Patients who received these implants should contact their healthcare provider or surgeon to discuss the recall and determine whether follow-up evaluation or revision surgery is necessary.
The recalled product
- Product
- Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
- Manufacturer
- Exactech, Inc.
- Hazard
- device-failure
- manufacturing-defect
- barrier-layer-missing
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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