510(k) K070978 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
ZIMMER SEGMENTAL SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 3, 2007 |
| Received | Apr 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2017 | Zimmer Biomet, Inc. Zimmer Segmental System, ZSS Distal Femur. Sizes as follows:
a. Size B-LT (Item No. 00585001201);
b. Size B-RT (Item No. 00585001202);
c. Size C-LT (Item No. 00585001301);
d. Size C-RT (Item Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental malefemale taper, 200mm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 18x250mm bwd, Sterile, Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 19x250mm bwd, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Jan 17, 2014 | Zimmer, Inc. Zimmer Segmental Systems; Polyethylene Inserts, Size B.
Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty. Terminated |
KRO | None listed |
| Jan 17, 2014 | Zimmer, Inc. Zimmer Segmental Systems; Polyethylene Inserts, Size C.
Knee replacement. Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.