FDAFDA · Food and drugs·Recall number Z-2131-2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Published July 28, 2021 · Recall initiated: June 29, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Distribution US nationwide.
- Lot
- All serial numbers. UDI-DI numbers: 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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