Skip to content

Novation recallZ-2128-2021 · Exactech, Inc. · initiated Jun 29, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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.

Recall details

Recall number
Z-2128-2021
Status
Open, Classified
Initiated by the company
Jun 29, 2021
Posted by the FDA
Jul 22, 2021
Recalling firm
Exactech, Inc.
Quantity
89,050 total
Product code
LZO
FDA submissions
K070479
Distribution
Distribution US nationwide.

Product description

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.

Code information (models, lots, serial numbers)

All serial numbers. UDI-DI numbers: 10885862024329, 10885862024336, 10885862024343, 10885862024350

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

45 devices cleared under K070479 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88126).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page