Z-0442-2013 Class II Terminated
FDA device recall Z-0442-2013 was initiated by Biomet, Inc. on Nov 6, 2012 and is designated Class II. Reason for recall: It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. The recall status is terminated (terminated Aug 28, 2013). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 5, 2012
- Initiation Date
- Nov 6, 2012
- Termination Date
- Aug 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
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.
Reason for Recall
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Distribution Pattern
Nationwide distribution: USA including states of: AZ, MD, and KS.
Code Information
Catalog Number: 192411 and Lot Number Identification: 244800
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0442-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026