Z-0442-2013Class II

Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant)...

Name: Z-0442-2013 Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant)...
Creator: Biomet, Inc.
Published: 2012-11-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-11-06 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint... on 2012-11-06. FDA classified it as Class II and gives the reason as "It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0442-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-06
Posted: 2012-11-27
Terminated: 2013-08-28
Recalling firm: Zimmer GmbH
Product: 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.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 4
Distribution: Nationwide distribution: USA including states of: AZ, MD, and KS.
Product codes and lots: Catalog Number: 192411 and Lot Number Identification: 244800

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0442-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0442-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27

Product code KWA

K070274Class IIIEcho Bi-Metric Press-Fit StemsBiomet Manufacturing Corp / cleared 2007-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)