FDA Device recall Z-0442-2013
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory dege…
- FDA Device
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory dege… by Biomet, citing it was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0442-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-06 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
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.
Reason
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Identifiers
| code_info | Catalog Number: 192411 and Lot Number Identification: 244800 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0442-2013%22
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