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Vitelene®

Aesculap AG · Model NV190E · UDI-DI 04046963973377

OQG Prescription
10
510(k) clearances
673
Adverse events
2
Recalls
119
Facilities

Description

VITELENE INSERT D 28MM SYM.

Recalls

DateFirmReason
2023-06-16Conformis, Inc.30mm screws were labeled as 25mm screws.
2013-01-24Stelkast CoFirm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.

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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.