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T-Han Delivery System
BONE SOLUTIONS, INC. · Model 4.2 x 180mm · UDI-DI 00850080243145
GEA
Prescription
10
510(k) clearances
1,037
Adverse events (1 deaths)
24
Recalls
377
Facilities
Description
The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2021-04-01 | CLINICAL LASERTHERMIA SYSTEMS AB | single use devices labeled as sterile may not have been adequately sterilized |
| 2020-01-15 | Cardinal Health 200, LLC | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile |
| 2019-07-16 | TeDan Surgical Innovations LLC | There was incorrect raw material used in the production of the identified lot. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
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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.