Home › STERNGOLD DENTAL LLC › ERA Implant® 3.25 Bone Tap 10, 13, 15mm
ERA Implant® 3.25 Bone Tap 10, 13, 15mm
STERNGOLD DENTAL LLC · Model 905521 · UDI-DI 00841549115035
DZI
Prescription
1
510(k) clearances
1,060
Adverse events
20
Recalls
80
Facilities
Description
A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
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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.