Device 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.
Z-0442-2013
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 63711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0442-2013
Official wording
Reason: It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Code information: Catalog Number: 192411 and Lot Number Identification: 244800
Distribution pattern: Nationwide distribution: USA including states of: AZ, MD, and KS.
Derived failure modes
-
Unknown
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.