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PEMF - PHYSIO-STIM
Orthofix US LLC · Model 655314-0101 · UDI-DI 18257200132003
LOF
Prescription
0
510(k) clearances
1,433
Adverse events (5 deaths)
5
Recalls
17
Facilities
Description
5314R, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and |
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and |
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and |
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and |
| 2020-12-17 | Bioventus, LLC | Product may contain white particulates that are microbial in nature. |
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Get your free API keyRead the docsData 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.