fda
2 records
FDA Device Recall: X-Guide Handpiece Adaptor Sleeve 3, Model P010727
2024-04-10
Class II — The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
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FDA Device Recall: X-Guide X-Mark Probe Tool -used for registering edentulous patients to the softw
2022-11-16
Class II — Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patie...
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