Novation XLE hip implant components recalled for missing barrier layer
Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.
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 risk-of-harm medical device (orthopedic hip implant) where a structural defect has been identified without reported illnesses or injuries, placing it in the High category per the severity rubric. FDA Class II designation without reported adverse events supports this classification.
Plain-English summary
Exactech, Inc. is recalling multiple Novation XLE hip implant system components due to the lack of an Ethylene Vinyl Alcohol (EVOH) barrier layer. The recalled items include various sizes and configurations of the Novation XLE system components across multiple SKUs and item numbers.
The missing EVOH barrier layer represents a structural defect in these medical implants. This defect could potentially compromise the integrity of the implant, prompting the recall as a precautionary measure.
The recall affects 87 units 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 healthcare provider or surgeon. Healthcare providers should refer to the FDA recall notice for complete product identification including item numbers, UDI-DI codes, and specific affected serial numbers.
The recalled product
- Product
- Novation 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.
- Affected units
- 87
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.
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