TSI
TEDAN SURGICAL INNOVATIONS, L.L.C. · Model BW-0002 · UDI-DI 00843059101331
10
510(k) clearances
4,143
Adverse events (4 deaths)
76
Recalls
840
Facilities
Description
BALFOUR BLADE, 2.6 X 3"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-01-31 | Technicality Inc. | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-08 | ENDO Pharmaceuticals Solutions, Inc. | No expiration dates printed on the packaging |
| 2022-11-02 | Arthrex, Inc. | The devices may be packaged with the wrong reamer size. |
| 2021-12-22 | FlexDex Inc. | The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in th |
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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.