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Synthes GmbH · Model SD03.503.512 · UDI-DI 10887587077901

DZI Prescription
1
510(k) clearances
1,053
Adverse events
20
Recalls
80
Facilities

Description

1.8MM DRILL BIT W/ 12MM STOP 50MM LONG/ J-LATCH COUPLING

Recalls

DateFirmReason
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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.