Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech recalls approximately 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in certain implant configurations.
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 for hip implant components with risk of mechanical failure through edge-loading and premature wear affecting certain patient populations. No reported illnesses or injuries documented in source; hazard is potential rather than current.
Plain-English summary
Exactech, Inc. is recalling approximately 89,050 Connexion GXL acetabular polyethylene liners, which are orthopedic hip implant components used in hip replacement systems. 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.
The affected liners were distributed nationwide in the United States and include all serial numbers with the following UDI-DI numbers: 10885862207043, 10885862207050, 10885862207067, 10885862303349, 10885862303462, 10885862303363. Catalog numbers include 132-40-XX Novation GXL Liner Lipped Anterior 40mm and Novation GXL Liner Lipped 40mm.
Patients who have received these implants should contact their healthcare provider for evaluation. Medical consultation is advised to determine whether additional monitoring or replacement is necessary based on individual implant configuration and positioning.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.
- 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 (6)
- All serial numbers. UDI-DI numbers: 10885862207043
- 10885862207050
- 10885862207067
- 10885862303349
- 10885862303462
- 10885862303363
Distribution
Distributed nationwide across the United States.
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