FDA Device Intelligence
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Staple, Fixation, Bone

FDA product code JDR · Class 2 · Orthopedic

2,292
Registered devices
2,647
Adverse events
36
Recalls
232
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-05-11In2bones USA, LLCDue to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
2022-09-27Synthes (USA) Products LLCThe subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant
2022-09-27Synthes (USA) Products LLCThe subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant
2022-09-27Synthes (USA) Products LLCThe subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant
2022-09-27Synthes (USA) Products LLCThe subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant
2022-08-30Synthes (USA) Products LLCDrill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tis
2022-03-10Wright Medical Technology, Inc.The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
2022-02-14Biomet, Inc.Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio
2022-02-14Biomet, Inc.Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio
2022-02-14Biomet, Inc.Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio

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