Exactech, Inc. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
All serial numbers. UDI-DI numbers: 10885862013491, 10885862013507, 10885862013514, 10885862013521, 10885862013538, 10885862013545, 10885862013569, 10885862013576, 10885862013583
Products Sold
All serial numbers. UDI-DI numbers: 10885862013491, 10885862013507, 10885862013514, 10885862013521, 10885862013538, 10885862013545, 10885862013569, 10885862013576, 10885862013583
Exactech, Inc. is recalling Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers due to Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Recommended Action
Per FDA guidance
The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026