Exactech GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech is recalling its Connexion GXL acetabular polyethylene liners used in hip implants because they may experience edge-loading and premature wear in certain patient configurations and surgical positioning. A total of 89,050 units were 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 a Class II recall with a theoretical risk of edge-loading and premature wear affecting a specific subset of patients. Per the rubric, risk-of-harm products where injury has not been reported are scored as High (3).
Plain-English summary
Exactech, Inc. is recalling its Connexion GXL acetabular polyethylene liners used in hip implant systems. The recall includes catalog numbers 136-28-XX, Novation GXL Liner +5mm Lateralized (28mm and 22mm ID variants), with all serial numbers affected. A total of 89,050 units were distributed nationwide in the United States.
The recall was initiated due to the risk of edge-loading and premature wear of the polyethylene liner. This risk is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
The FDA classified this as a Class II recall. Patients who have received one of these implants should consult with their surgeon or healthcare provider to discuss whether their individual implant configuration and surgical positioning may be affected and what follow-up care or monitoring may be appropriate.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. 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 (3)
- All serial numbers. UDI-DI numbers: 10885862024213
- 10885862024220
- 10885862024237
Distribution
Distributed nationwide across the United States.
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