510(k) K041549 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
ZIMMER TRABECULAR METAL HUMERAL STEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 1, 2004 |
| Received | Jun 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Zimmer, Inc. 00434811113, REF I4348-111-13
Zimmer Trabecular Metal Shoulder
Humeral Stem 48 Degrees
11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Terminated |
KWT | None listed |
| Dec 9, 2010 | Zimmer Inc. ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4 Terminated |
KWT | None listed |
| Dec 9, 2010 | Zimmer Inc. TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00.
The intramed Terminated |
KWT | None listed |
| Dec 9, 2010 | Zimmer Inc. Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3
The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrai Terminated |
KWT | None listed |
| Dec 9, 2010 | Zimmer Inc. Zimmer Trabecular Metal Humeral Stem 4-Part Fracture
Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3.
The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi Terminated |
KWT | None listed |
| Dec 9, 2010 | Zimmer Inc. Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4.
The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with s Terminated |
KWT | None listed |
| Nov 12, 2009 | Zimmer Inc. Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13.
Shoulder replacement surgery. Terminated |
HSD | None listed |
| Nov 12, 2009 | Zimmer Inc. Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13.
Shoulder replacement surgery. Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.