510(k) K070274 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
ECHO BI-METRIC PRESS-FIT STEMS
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 3, 2007 |
| Received | Jan 29, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2018 | Zimmer Biomet, Inc. ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem Terminated |
KWA | None listed |
| Jun 5, 2017 | Zimmer Biomet, Inc. ECHO POR FMRL NC 9X125, model # 192009 Terminated |
KWA | None listed |
| Nov 27, 2012 | Biomet, Inc. 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 avascula Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.