FDA Device Intelligence
Home › LEONE SPA › LEONE SPA

LEONE SPA

LEONE SPA · Model 000-1512-02 · UDI-DI 08033707071501

OAT Prescription
1
510(k) clearances
337
Adverse events
3
Recalls
55
Facilities

Description

MINI ORTHODONTIC IMPLANT HIGH D1,5 L12mm

Recalls

DateFirmReason
2013-07-12Ormco/SybronendoOrmco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially caus
2007-09-28Straumann USA LLCSticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
2007-09-28Straumann USA LLCSticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.