FDA Medical Device Recalls (openFDA)
OSSTEM Implant Co., Ltd.: Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
- Recall number
- Z-0313-2026
- Recalling firm
- OSSTEM Implant Co., Ltd.
- Product
- Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
- Status
- Open, Classified
- Initiated
- 2025-08-26
- Posted
- 2025-11-05
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Osstem Implant issued notification to customers, titled "URGENT: MEDICAL DEVICE CORRECTION", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information.
- Quantity
- not on file
- Distribution
- U.S.
- Lot, serial or model codes
- UDI Codes: 08800000995793 and 08800000995526.
- 510(k) numbers
- ["K183475"]
- PMA numbers
- not on file
- Product code
- OAS
- Firm FEI
- 3003394081
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28