FDAClass IIJuly 28, 2021

Exactech Connexion GXL acetabular polyethylene liners recall

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm…

Why was Exactech Connexion GXL acetabular polyethylene liners recalled?

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers. UDI-DI numbers: 10885862023063, 10885862023070, 10885862023087, 10885862023094, 10885862023100, 10885862023117, 10885862023124, 10885862023148, 10885862023155, 10885862023162, 10885862303387, 10885862303394, 10885862303400

Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm…
Recalling firm
Exactech, Inc.
Quantity
89,050 total
Distribution
Distribution US nationwide.
Recall date
July 28, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls