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Device, Prosthesis Alignment

FDA product code IQO · Class 1 · Physical Medicine

214
Registered devices
48
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2012-07-27Biomet U.K., Ltd.A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem
2007-09-11Stryker Howmedica Osteonics Corp.The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that t

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