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BIO-RAY A-1 Anchor Screw System

MICROWARE PRECISION CO., LTD. · Model A-1HS-421509 · UDI-DI 04719879413090

OAT Prescription
1
510(k) clearances
335
Adverse events
3
Recalls
56
Facilities

Description

A-1H Anchorage Screw, Ø1.5 x L9mm, Single Hook, Square Hole

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.

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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.