Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless… — Class II medical device recall Z-0442-2013
Terminated recall by Biomet, Inc., reported 2012-12-05, distributed nationwide. It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm ste
| Recall number | Z-0442-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-11-06 |
| Classified | 2012-11-27 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2013-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Model numbers | 192411 |
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 for recall
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0442-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.