510(k) K031280 ยท JDX Instrument, Surgical, Sonic And Accessory/Attachment
ULTRA-DRIVE 3
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 22, 2003 |
| Received | Apr 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2019 | Zimmer Biomet, Inc. Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone ceme Terminated |
JDX | None listed |
| Jun 4, 2019 | Zimmer Biomet, Inc. Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bo Terminated |
JDX | None listed |
| May 10, 2012 | Biomet, Inc. Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581
Incorrect Picture Label, Trochanter Plate (50-60 mm) Ma Terminated |
JXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.