OSSTEM Implant Co., Ltd.: Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: U.S. Quantity: N/A Lot/code info: UDI Codes: 08800000996059 and 08800000996042.

UPC codes

08800000996059, 08800000996042

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.