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SYNTHES (U.S.A.) LP · Model 03.000.106S · UDI-DI 10886982064936

DZI HWE HBE ERL Prescription

510(k) clearances

1,053

Adverse events

Recalls

Facilities

Description

BURR DRUM-SHAPED S Ø 9.1MM HEAD LENGTH 7.9MM

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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Data 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.