FDA Device Intelligence
HomeDevice types › HRS

Plate, Fixation, Bone

FDA product code HRS · Class 2 · Orthopedic

84,439
Registered devices
38,818
Adverse events
286
Recalls
1,321
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-05-28Acumed LLCDue to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U

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