Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2132-2021)

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 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component.

Product Classification:

Class II

Date Initiated: June 29, 2021

Date Posted: July 28, 2021

Recall Number: Z-2132-2021

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: 138-32-XX: 10885862024732, 10885862024749, 10885862024756, 10885862024763, 10885862024770. 138-36-XX: 10885862024817, 10885862024824, 10885862024831, 10885862024848, 10885862024886, 10885862024893, 10885862024909, 10885862024916. 138-40-XX: 10885862208804, 10885862208811, 10885862208828.

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated