RecallDepth

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.

Company
Exactech, Inc.
Recall Initiated
June 29, 2021
Posted
July 22, 2021
Recall Number
Z-2133-2021
Quantity
89,050 total
Firm Location
Gainesville, FL

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

Distribution US nationwide.

Lot / Code Info

All serial numbers. UDI-DI numbers: 10885862023247, 10885862023254, 10885862023261, 10885862023278, 10885862207029, 10885862023315, 10885862023322, 10885862023339, 10885862023346, 10885862303325, 10885862303417, 10885862303424, 10885862303431, 10885862303448

Root Cause

Unknown/Undetermined by firm

Action Taken

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.

More recalls by Exactech, Inc.

View all recalls by this company →