510(k) K060692 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
COMPREHENSIVE PRIMARY SHOULDER STEMS
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, May 30, 2006 |
| Received | Mar 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060692
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2020 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive Terminated |
MBF | None listed |
| Oct 10, 2018 | Zimmer Biomet, Inc. Comprehensive Mini Stem, Item No. 113631: Terminated |
MBF | None listed |
| Dec 8, 2017 | Zimmer Biomet, Inc. Humeral Stem 83mm(Size 17)
Product Usage:
Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty Terminated |
HSD | None listed |
| Dec 8, 2017 | Zimmer Biomet, Inc. Humeral Stem 55mm(Size 13)
Product Usage:
Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty Terminated |
HSD | None listed |
| Jun 5, 2017 | Zimmer Biomet, Inc. COMP PRIMARY STEM 8MM MINI, model # 113628 Terminated |
MBF | None listed |
| Jun 11, 2015 | Biomet, Inc. Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glen Terminated |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.