Home › Device types › JDC
Prosthesis, Elbow, Constrained, Cemented
FDA product code JDC · Class 2 · Orthopedic
1,264
Registered devices
3,056
Adverse events
20
Recalls
29
510(k) clearances
Devices with this code
DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, LLCDJO SURGICAL — Encore Medical, L.P.LATITUDE EV™ — TORNIER, INC.SOLAR — Howmedica Osteonics Corp.Arcos Modular Revision Hip System — Biomet Orthopedics, LLCCOMPRESS DEVICE — Biomet Orthopedics, LLCDISCOVERY ELBOW SYSTEM — Biomet Orthopedics, LLCComprehensive® SRS Instrument — Biomet Orthopedics, LLCTEMA Elbow — LIMACORPORATE SPATEMA Elbow — LIMACORPORATE SPAArcos Modular Revision Hip System — Biomet Orthopedics, LLCArcos Modular Revision Hip System — Biomet Orthopedics, LLCDISCOVERY ELBOW SYSTEM — Biomet Orthopedics, LLCLatitude™ EV — TORNIER, INC.Latitude™ - Elbow — TORNIER, INC.DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, LLCNexel® — Zimmer, Inc.Comprehensive® SRS Instrument — Biomet Orthopedics, LLCCompress® Device — Biomet Orthopedics, LLCLatitude™ - Elbow — TORNIER, INC.Latitude™ - Elbow — TORNIER, INC.COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, LLCZimmer® Nexel® Total Elbow — Zimmer, Inc.SOLAR — Howmedica Osteonics Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-25 | Limacorporate S.p.A | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. |
| 2019-12-12 | Zimmer Biomet, Inc. | The lot contained two outer pins instead of one outer and one inner pin. |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2018-01-24 | Zimmer Biomet, Inc. | One lot of humeral stem implants do not include the humeral bushing components. |
| 2016-08-16 | Zimmer Biomet, Inc. | 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 |
| 2014-05-15 | Biomet, Inc. | 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 pat |
| 2012-11-19 | Zimmer, Inc. | 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 |
| 2012-11-19 | Zimmer, Inc. | 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 |
| 2011-12-14 | Biomet, Inc. | A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles. |
| 2011-04-29 | Biomet, Inc. | 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 condyl |
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