Exactech Connexion GXL Hip Implant Liners Risk Premature Wear
Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.
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: FDA Class II recall of orthopedic implant component with identified risk of premature wear and edge-loading, but limited to a specific subset of patient configurations with no reported illnesses or injuries. The risk-of-harm nature of medical device failure supports High severity per the rubric.
Plain-English summary
Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners, components used in hip replacement systems. The recalled catalog numbers are 130-40-XX, including the Novation GXL Liner, Neutral, 40mm configuration, all serial numbers.
The FDA determined there is a risk of edge-loading and premature prosthesis wear in a specific subset of patients depending on their implant configuration and surgical implant positioning. This risk could affect the longevity of the hip implant.
The recall involves 89,050 units distributed nationwide in the United States.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- edge-loading
- premature-wear
- implant-failure
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: 10885862207098
- 10885862207104
- 10885862207111
Distribution
Distributed nationwide across the United States.
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