FDA Device Intelligence
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Prosthesis, Elbow, Constrained, Cemented

FDA product code JDC · Class 2 · Orthopedic

1,264
Registered devices
3,105
Adverse events
21
Recalls
29
510(k) clearances

Devices with this code

Arcos Modular Revision Hip System — Biomet Orthopedics, LLCLatitude™ - Elbow — TORNIER, INC.Comprehensive® SRS — Biomet Orthopedics, LLCLATITUDE EV™ — TORNIER, INC.DJO SURGICAL — Encore Medical, L.P.Nexel® — Zimmer, Inc.COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, LLCArcos Modular Revision Hip System — Biomet Orthopedics, LLCLatitude™ - Elbow — TORNIER, INC.Nexel® — Zimmer, Inc.Arcos Modular Revision Hip System — Biomet Orthopedics, LLCTotal Elbow — Howmedica Osteonics Corp.Arcos Modular Revision Hip System — Biomet Orthopedics, LLCTEMA Elbow — LIMACORPORATE SPATEMA Elbow — LIMACORPORATE SPADJO SURGICAL — Encore Medical, L.P.Arcos Modular Revision Hip System — Biomet Orthopedics, LLCArcos Modular Revision Hip System — Biomet Orthopedics, LLCComprehensive® SRS — Biomet Orthopedics, LLCCOMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, LLCArcos Modular Revision Hip System — Biomet Orthopedics, LLCComprehensive SRS — Biomet Orthopedics, LLCComprehensive® SRS Instrument — Biomet Orthopedics, LLCCOMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, LLC

Recent recalls

DateFirmReason
2026-07-30Howmedica Osteonics Corp.Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential f
2023-01-25Limacorporate S.p.ADue to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
2019-12-12Zimmer Biomet, Inc.The lot contained two outer pins instead of one outer and one inner pin.
2019-10-10Zimmer Biomet, Inc.Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
2018-01-24Zimmer Biomet, Inc.One lot of humeral stem implants do not include the humeral bushing components.
2016-08-16Zimmer 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
2014-05-15Biomet, 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
2012-11-19Zimmer, 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
2012-11-19Zimmer, 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
2011-12-14Biomet, Inc.A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.