Home › STERNGOLD DENTAL LLC › TRU® Prosthetic Screw RP .050" Hex, Ti
TRU® Prosthetic Screw RP .050" Hex, Ti
STERNGOLD DENTAL LLC · Model 904657 · UDI-DI 00841549112874
NHA
Prescription
1
510(k) clearances
8,783
Adverse events (1 deaths)
225
Recalls
380
Facilities
Description
TRU Prosthetic Screw RP .048" Hex. These Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Straumann USA LLC | There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i |
| 2026-03-27 | Straumann USA LLC | Includes an incorrect screw seat interface. |
| 2026-03-27 | Straumann USA LLC | Includes an incorrect screw seat interface. |
| 2026-03-17 | Straumann USA LLC | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre |
| 2026-03-17 | Straumann USA LLC | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre |
| 2025-09-30 | Prismatik Dentalcraft, Inc. | Incorrect titanium screw, packaged with dental implant. |
| 2025-06-25 | Preat Corp | Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the |
| 2025-06-24 | Preat Corp | Due to manufacturing error, digital analog rotational feature is 180 degrees off. |
| 2025-04-17 | Straumann USA LLC | Incorrect blister labelling. |
| 2025-04-02 | Preat Corp | Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the ass |
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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.