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JMU

JMU DENTAL, INC · Model 29601004 · UDI-DI 00840456205891

GBX
10
510(k) clearances
5,886
Adverse events (26 deaths)
82
Recalls
239
Facilities

Description

JMU Disposable Dental Implant Irrigation Tubing, Universal Type, EO Gas Sterilized, 1pc/bag, 300pcs/case -Recommended for W&H, NSK, COXO, WOODPECKER, SAESHIN, SAEYANG's Implant Devices.

Recalls

DateFirmReason
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2024-03-27Cardinal Health 200, LLCCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril
2024-03-27Cardinal Health 200, LLCCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril
2024-03-27Cardinal Health 200, LLCCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.