FDA Device Intelligence
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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

Recent recalls

DateFirmReason
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.
2011-04-29Biomet, 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.