Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2116-2021)

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 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.

Product Classification:

Class II

Date Initiated: June 29, 2021

Date Posted: July 28, 2021

Recall Number: Z-2116-2021

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: 10885862021984, 10885862021991, 10885862022004, 10885862022011, 10885862022028, 10885862022035, 10885862022059, 10885862022066, 10885862022073

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated