FDAFDA · Food and drugs·Recall number Z-2113-2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. 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: 10885862013606, 10885862013613, 10885862013620, 10885862013637, 10885862013644, 10885862013651, 10885862013668, 10885862013675
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.