510(k) K001989 ยท JDC Prosthesis, Elbow, Constrained, Cemented
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 25, 2000 |
| Received | Jun 29, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2019 | Zimmer Biomet, Inc. Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139
The device is a Humeral component; elbow joint metal/p Terminated |
JDC | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Coorad Morrey Total Elbow, Item Nos. 32810502501
32810502701
32810502900
32810503000
32810600012
32810600013
32855510796
32855510797
32855510799
32855510800
32855510801
32855510805
32855510822
3285551 Terminated |
JDC | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912) Terminated |
JDC | None listed |
| Sep 8, 2016 | Zimmer Biomet, Inc. Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity i Terminated |
JDC | None listed |
| Dec 18, 2012 | Zimmer, Inc. Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1
Product Usage: The ulnar and humeral components are connected by placing the h Terminated |
JDC | None listed |
| Apr 2, 2009 | Zimmer Inc. Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04.
The device is utilized for a total elbow arthrop Terminated |
JDC | None listed |
| Apr 2, 2009 | Zimmer Inc. Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile, Zimmer Inc, Warsaw, IN; REF 32-8105-027-06.
The device is utilized for a total elbow arthropl Terminated |
JDC | None listed |
| Apr 2, 2009 | Zimmer Inc. Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-01.
The device is utilized for a total elbow a Terminated |
JDC | None listed |
| Apr 2, 2009 | Zimmer Inc. Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-02.
The device is utilized for a total elbow Terminated |
JDC | None listed |
| Jul 20, 2004 | Zimmer Inc. Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01. Terminated |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.