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Anteralign Spinal System with Titan nanoLock Surface technology
MEDTRONIC SOFAMOR DANEK, INC. · Model 4680100 · UDI-DI 00763000226237
KCT
Prescription
1
510(k) clearances
343
Adverse events
38
Recalls
292
Facilities
Description
TRAY 4680100 ANTERALIGN INSTRUMENTS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-23 | Jewel Precision Sheet Metal & Machining Co, Inc. | The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the ch |
| 2025-05-22 | Jewel Precision Sheet Metal & Machining Co, Inc. | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. |
| 2025-05-01 | Implant Direct Sybron Manufacturing LLC | The Drill stop kit contains incorrect components. |
| 2023-04-06 | Karl Storz Endoscopy | Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tra |
| 2023-04-05 | Karl Storz Endoscopy | Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the t |
| 2023-01-30 | Carefusion 2200 Inc | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.