Prosthesis, Elbow, Constrained, Cemented
Orthopedic · 21 CFR 888.3150
Recent MDR events
3,057 adverse event reports on file
- ELBOW TORQUE DRIVERJul 30, 2026MalfunctionZimmer Biomet, Inc.0001822565-2026-02717
- DJO SURGICALJul 30, 2026InjuryEncore Medical L.p.1644408-2026-01448
- DJO SURGICALJul 29, 2026InjuryEncore Medical L.p1644408-2026-01461
- COMPR SRS HUMERAL COUPLERJul 27, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02182
- DJO SURGICALJul 27, 2026InjuryEncore Medical L.p.1644408-2026-01408
- COONRAD MORREY ELBOWJul 22, 2026InjuryZimmer Biomet, Inc.0001822565-2026-02659
- CMD 22-1166 PROMADE ELBOWJul 21, 2026InjuryLimacorporate S.p.a.3008021110-2026-00266
- NEXEL ELBOWJul 20, 2026InjuryZimmer Biomet, Inc.0001822565-2026-02616
- NEXEL ELBOWJul 20, 2026InjuryZimmer Biomet, Inc.0001822565-2026-02621
- NEXEL ELBOWJul 20, 2026InjuryZimmer Biomet, Inc.0001822565-2026-02617
Event type breakdown
Recalls
20 recall events for this product code
- Limacorporate S.p.AOpen, ClassifiedMar 16, 2023
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Z-1261-2023 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedMar 14, 2018
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
One lot of humeral stem implants do not include the humeral bushing components.
Z-1239-2018 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 8, 2016
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 usin
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
Z-2752-2016 · View FDA record ↗ - Biomet, Inc.TerminatedJun 26, 2014
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY.
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
Z-1925-2014 · View FDA record ↗ - Zimmer, Inc.TerminatedDec 18, 2012
COONMAD/MORREY TOTAL ELBOW
Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .
Z-0537-2013 · View FDA record ↗ - Zimmer, Inc.TerminatedDec 18, 2012
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1
Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .
Z-0538-2013 · View FDA record ↗ - Biomet, Inc.TerminatedFeb 21, 2012
Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581.
A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
Z-1071-2012 · View FDA record ↗ - Biomet, Inc.TerminatedJun 24, 2011
Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, I
The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.
Z-2660-2011 · View FDA record ↗ - Zimmer Inc.TerminatedApr 2, 2009
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04.
The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
Z-1053-2009 · View FDA record ↗ - Zimmer Inc.TerminatedApr 2, 2009
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile, Zimmer Inc, Warsaw, IN; REF 32-8105-027-06.
The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
Z-1054-2009 · View FDA record ↗
Registered firms
191 firms currently registered for this product code
Zimmer, Inc.
WARSAW, IN, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Aps Materials, Inc.
DAYTON, OH, US
Phillips Precision Inc
Elmwood Park, NJ, US
Zimmer Pte. Ltd.
Singapore South East, SG
Steris Spa
SERIATE Bergamo, IT
Sterigenics Us Llc
Gurnee, IL, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Tornier Inc.
Columbia City, IN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Isomedix Operations, Inc.
Libertyville, IL, US
Micropulse Inc
Columbia City, IN, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Sterigenics Us, Llc
Lewis Center, OH, US
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Lynx Medical Pennsylvania
ERIE, PA, US
Biomet, Inc.
WARSAW, IN, US
Limacorporate S.p.a.
Villanova di San Daniele Udine, IT
Limacorporate S.p.a.
Calatafimi Segesta (TP) Sicilia, IT
Centex Machining, Inc.
Round Rock, TX, US
510(k) clearances
29 clearances for this product code
- Lima Corporate S.P.A.Feb 16, 2019
K181362 · TEMA Elbow System
- Zimmer, Inc.Jan 28, 2019
K181307 · Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
- Biomet Manufacturing CorpFeb 3, 2016
K153398 · Comprehensive SRS/Nexel Elbow
- Zimmer, Inc.Apr 23, 2015
K150501 · Zimmer Nexel Total Elbow Ulnar Cement Diverter
- Zimmer, Inc.Mar 12, 2013
K123862 · ZIMMER NEXEL TOTAL ELBOW
- Biomet Manufacturing CorpMar 25, 2009
K090473 · DISCOVERY ELBOW - X-SMALL
- DePuy Orthopaedics, Inc.Apr 14, 2006
K060696 · ACCLAIM TOTAL ELBOW SYSTEM
- Zimmer, Inc.Dec 9, 2005
K053189 · COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES