Z-2113-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- June 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,050 total
Product Description
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.
Reason for Recall
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Distribution Pattern
Distribution US nationwide.
Code Information
All serial numbers. UDI-DI numbers: 10885862013606, 10885862013613, 10885862013620, 10885862013637, 10885862013644, 10885862013651, 10885862013668, 10885862013675