FDA (Devices) recall action 97869
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
The agency’s own wording, quoted from the enforcement report.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T1 because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.