Biomet, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0442-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: November 6, 2012
Date Posted: December 5, 2012
Recall Number: Z-0442-2013
Event ID: 63711
Reason for Recall:

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

Status: Terminated
Product Quantity: 4
Code Information:

Catalog Number: 192411 and Lot Number Identification: 244800

Distribution Pattern:

Nationwide distribution: USA including states of: AZ, MD, and KS.

Voluntary or Mandated:

Voluntary: Firm initiated