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Vision RingLoc Shell 50 mm Size 23. Hip joint replacement… recallZ-2483-2015 · Biomet, Inc. · initiated Jul 28, 2015

Class II Terminated All recalls posted in August 2015

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 Biomet, 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

The device was assembled without screw hole plugs.

FDA root cause category: Under Investigation by firm

What the company is doing

Zimmer Biomet issued notices on July 28, 2015, via FedEx overnight mail and e-mail to customers. Customers were asked to return response forms and recalled devices to Zimmer Biomet. Customers with questions may call Seth Pixton, Field Action Specialist, at 574-372-1570, Monday through Friday from 8:00 am to 5:00 pm, or e-mail at: [email protected].

Recall details

Recall number
Z-2483-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 28, 2015
Posted by the FDA
Aug 29, 2015
Recalling firm
Biomet, Inc.
Quantity
5
Product code
LPH
FDA submissions
K093235
Distribution
Distributed in Canada and Japan.

Product description

Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.

Code information (models, lots, serial numbers)

Part Number:135250; Lot Number:946410

Other devices under the same FDA submission

1 device cleared under K093235 — 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