Hip implant acetabular liners recalled for edge-loading and premature wear
Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.
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 involving a risk-of-harm orthopedic implant product. No illnesses or injuries have been reported, and the risk is limited to a specific subset of patients based on implant configuration and surgical positioning. Per the rubric, risk-of-harm products where injury has not been reported score High (3).
Plain-English summary
Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners used in orthopedic hip implant systems. The recalled products include the Acumatch GXL 15 Degree Liner (32mm), Novation GXL Liner Lipped Anterior (32mm), and Novation GXL Liner Lipped (32mm). Approximately 89,050 units with all serial numbers have been distributed nationwide.
The recalled liners carry a risk of edge-loading and premature prosthesis wear. This risk applies to a specific subset of patients who have certain implant configurations and specific surgical positioning of the implant.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- edge-loading
- prosthesis-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 (14)
- All serial numbers. UDI-DI numbers: 10885862023247
- 10885862023254
- 10885862023261
- 10885862023278
- 10885862207029
- 10885862023315
- 10885862023322
- 10885862023339
- 10885862023346
- 10885862303325
- 10885862303417
- 10885862303424
- 10885862303431
- 10885862303448
Distribution
Distributed nationwide across the United States.
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