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Device, Fixation, Proximal Femoral, Implant

FDA product code JDO · Class 2 · Orthopedic

896
Registered devices
286
Adverse events
8
Recalls
23
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2020-01-07Zimmer Biomet, Inc.Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
2018-08-09Biomet UK Ltd.HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
2018-08-09Biomet UK Ltd.HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
2018-08-09Biomet UK Ltd.HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
2018-08-09Biomet UK Ltd.HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
2017-12-21Howmedica Osteonics Corp.From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to
2016-06-10Biomet, Inc.The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be rem
2013-10-11Zimmer, Inc.Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this r

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