Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2112-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 29, 2021

Date Posted: July 28, 2021

Recall Number: Z-2112-2021

Event ID: 88126

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.

Status: Ongoing

Product Quantity: 89,050 total

Code Information:

All serial numbers. UDI-DI numbers: 10885862013491, 10885862013507, 10885862013514, 10885862013521, 10885862013538, 10885862013545, 10885862013569, 10885862013576, 10885862013583

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated