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P-K Titanium Motility Peg System

INTEGRATED ORBITAL IMPLANTS INC · Model I00100 · UDI-DI 00854066006175

MQU Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
5
Facilities

Recalls

DateFirmReason
2006-12-20Integrated Orbital Implants IncThe threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identif

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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.