Exactech Connexion GXL hip implant liners recalled due to premature wear risk
Exactech is recalling 89,050 Connexion GXL hip implant liners distributed nationwide due to a risk of edge-loading and premature wear in certain patient 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: This FDA Class II recall addresses a risk-of-harm medical device where injury has not yet been reported. The potential for premature implant wear and edge-loading could lead to device failure in specific patient populations, but no hospitalizations or injuries have been documented.
Plain-English summary
Exactech, Inc. is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners distributed across the United States. These orthopedic implant components are used in specific hip implant systems, including catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG, and MCS GXL Liner 5/15 DEG.
The recall addresses a risk of edge-loading and premature prosthesis wear that may occur in certain patients with specific implant configurations and surgical positioning. No injuries or illnesses have been reported to date.
Patients who have received these implants should contact their surgeon or healthcare provider with any concerns about their implant or if they experience hip-related symptoms.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. 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 (8)
- All serial numbers. UDI-DI numbers: 10885862013606
- 10885862013613
- 10885862013620
- 10885862013637
- 10885862013644
- 10885862013651
- 10885862013668
- 10885862013675
Distribution
Distributed nationwide across the United States.
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