Hip implant liners recalled due to risk of premature wear
Exactech is recalling 89,050 hip implant liners due to risk of edge-loading and premature wear in specific patient and surgical configurations affecting a subset of patients.
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 theoretical risk of premature wear and device failure in a specific subset of patients. No illnesses, injuries, or deaths have been reported in the source text.
Plain-English summary
Exactech, Inc. is recalling 89,050 Connexion GXL acetabular polyethylene liners used in hip replacement systems. These are components of orthopedic hip implant systems distributed nationwide in the United States. The recalled products include specific catalog numbers: 104-36-XX, MCS +5GXL Liner 5/15 DEG, and MCS GXL Liner 5/15 DEG.
The FDA classified this as a Class II recall due to a risk of edge-loading and premature prosthesis wear. These complications may occur in a specific subset of patients when certain implant configurations are combined with specific surgical positioning techniques.
The recall affects patients who received these particular hip implant liners with the identified catalog numbers and serial numbers listed by the FDA. Patients with these implants may be at risk of device degradation over time.
Patients who have received these implants should consult with their surgeon or healthcare provider about whether their specific implant is affected and what monitoring or follow-up care may be appropriate.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- premature-wear
- device-degradation
- hip-implant-failure
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 (5)
- All serial numbers. UDI-DI numbers: 10885862013682
- 10885862013699
- 10885862013705
- 10885862013712
- 10885862013729
Distribution
Distributed nationwide across the United States.
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