Exactech Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain patient configurations. No injuries have been reported.
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 recall is scored as High (3) because it involves a hip implant component that poses potential for premature wear and failure, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported. The FDA Class II classification without reported hospitalizations prevents a Severe score, but the structural risk to a vital implant component justifies this High rating.
Plain-English summary
Exactech, Inc. is recalling 89,050 Exactech Connexion GXL acetabular polyethylene liners (catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm), which are components used in orthopedic hip implant systems distributed nationwide in the United States.
The liners are being recalled due to a risk of edge-loading and premature prosthesis wear in a specific subset of patients with certain implant configurations and surgical implant positioning. This risk could potentially lead to implant failure, though no injuries or illnesses have been reported to date.
Patients who believe they have received this product should contact their healthcare provider or surgeon for further evaluation and guidance.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- edge-loading
- premature-prosthesis-wear
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All serial numbers. UDI-DI numbers: 10885862220301
- 10885862220318
- 10885862220325
Distribution
Distributed nationwide across the United States.
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