Skip to content

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23… recallZ-2661-2017 · Medacta Usa Inc · initiated May 19, 2017

Class II Terminated All recalls posted in June 2017

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 Medacta Usa 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

One lot of product does not include a screw for attachment to the tibial base plate.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.

Recall details

Recall number
Z-2661-2017
Recall class
Class II
Status
Terminated
Initiated by the company
May 19, 2017
Posted by the FDA
Jun 12, 2017
Recalling firm
Medacta Usa Inc
Quantity
4 units
Product code
KRO
FDA submissions
K130299
Distribution
CA, AZ, NC, Israel, France

Product description

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Code information (models, lots, serial numbers)

Lot # 163646

Other devices under the same FDA submission

55 devices cleared under K130299 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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