Exactech Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in hip implants face premature wear risk in certain patient and implant configurations. Consult your orthopedic surgeon if you have this device.
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 medical device recall describing a theoretical risk of premature implant wear in specific patient/implant/positioning combinations. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
Exactech, Inc. is recalling approximately 89,050 Connexion GXL acetabular polyethylene liners used in hip implant systems. These liners are components of the Novation GXL and other hip implant systems identified by specific catalog numbers.
The FDA has determined that edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. This could potentially affect the longevity and function of the implant.
If you have received one of these hip implant components, consult with your orthopedic surgeon. Your surgeon can assess whether your specific implant configuration and positioning creates risk and discuss appropriate monitoring or follow-up care.
Exactech has distributed these liners nationwide throughout the United States.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- device-failure
- edge-loading
- premature-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 (2)
- All serial numbers. UDI-DI numbers: 10885862303370
- 10885862022967
Distribution
Distributed nationwide across the United States.
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