Exactech GXL Acetabular Hip Implant Liners Recalled for Premature Wear Risk
Exactech, Inc. is recalling 89,050 Connexion GXL and Novation GXL acetabular hip implant liners due to risk of edge-loading and premature prosthesis wear in certain patients. The risk depends on implant configuration and surgical positioning.
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 recall of a medical device where edge-loading and premature prosthesis wear could occur in a specific subset of patients based on implant configuration and surgical positioning. No illnesses or hospitalizations have been reported. The recall meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling Connexion GXL and Novation GXL acetabular polyethylene liners used in hip replacement systems. The recall affects approximately 89,050 units distributed nationwide. All serial numbers of the affected catalog numbers are included.
The company identified a risk of edge-loading and premature prosthesis wear in a specific subset of patients with certain implant configurations and surgical implant positioning. This is an FDA Class II recall indicating a medical device that could cause serious adverse health consequences.
Patients with these implants should contact their healthcare provider or Exactech, Inc. for information about their individual risk based on their specific implant configuration and surgical positioning. Healthcare providers can identify affected patients using the UDI-DI numbers and catalog numbers in the FDA recall notice.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant
- Manufacturer
- Exactech, Inc.
- Hazard
- 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 (13)
- All serial numbers. UDI-DI numbers: 10885862023063
- 10885862023070
- 10885862023087
- 10885862023094
- 10885862023100
- 10885862023117
- 10885862023124
- 10885862023148
- 10885862023155
- 10885862023162
- 10885862303387
- 10885862303394
- 10885862303400
Distribution
Distributed nationwide across the United States.
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