Hip Implant Acetabular Liners Recalled for Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in orthopedic hip implants are recalled due to risk of edge-loading and premature wear in certain configurations. The recall affects 89,050 units distributed nationwide.
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 with no reported injuries or illnesses. The hazard (premature prosthesis wear) represents a functional degradation risk affecting only a specific subset of patients based on implant configuration and surgical positioning, fitting the rubric criterion for risk-of-harm products with no reported injury.
Plain-English summary
Exactech, Inc. is recalling 89,050 Connexion GXL acetabular polyethylene liners used in orthopedic hip implant systems. These components are used in specific Acumatch GXL and Novation GXL systems, identified by catalog numbers and UDI codes, and were distributed across the United States.
The recalled liners present a risk of edge-loading and premature prosthesis wear, but only in a specific subset of patients with certain implant configurations and particular surgical positioning.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Category
- Medical Device — Hip Implant
- 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 (9)
- All serial numbers. UDI-DI numbers: 10885862021984
- 10885862021991
- 10885862022004
- 10885862022011
- 10885862022028
- 10885862022035
- 10885862022059
- 10885862022066
- 10885862022073
Distribution
Distributed nationwide across the United States.
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