510(k) K010212 ยท MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
OFFSET TIBIAL TRAY
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Jan 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2018 | Zimmer Biomet, Inc. Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340
Product is used in Total Knee Arthroplasty Terminated |
JWH | None listed |
| Dec 17, 2012 | Biomet, Inc. Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490
Sterile, QTY.1
Product Usage:
Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement compo Terminated |
MBV | None listed |
| Apr 7, 2009 | Biomet, Inc. Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491.
The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients Terminated |
JDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.