Skip to content

Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm… recallZ-0442-2013 · Biomet, Inc. · initiated Nov 6, 2012

Class II Terminated All recalls posted in November 2012

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

It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

FDA root cause category: Labeling Change Control

What the company is doing

The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed FAX Back Response Form. Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for your shipment. Questions related to notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recall details

Recall number
Z-0442-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 6, 2012
Posted by the FDA
Nov 27, 2012
Recalling firm
Biomet, Inc.
Quantity
4
Product code
KWA
FDA submissions
K070274
Distribution
Nationwide distribution: USA including states of: AZ, MD, and KS.

Product description

Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.

Code information (models, lots, serial numbers)

Catalog Number: 192411 and Lot Number Identification: 244800

Other devices under the same FDA submission

38 devices cleared under K070274 — 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