Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems are recalled due to risk of edge-loading and premature wear in certain patients. The 89,050 affected units were 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 medical device recall with risk of premature device failure. No illnesses or injuries reported. Per rubric, this is a risk-of-harm product where injury has not yet been reported, warranting High severity.
Plain-English summary
Exactech Connexion GXL acetabular polyethylene liners, used as components in Novation GXL hip replacement systems, are being recalled. These liners are orthopedic hip implant components, and approximately 89,050 units were distributed nationwide.
The liners carry a risk of edge-loading and premature prosthesis wear in a specific subset of patients with certain implant configurations and surgical positioning. The specific risk depends on the particular combination of implant design and the position in which the implant was placed during surgery.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. 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 (4)
- All serial numbers. UDI-DI numbers: 10885862024329
- 10885862024336
- 10885862024343
- 10885862024350
Distribution
Distributed nationwide across the United States.
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