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Thermasplint

Whitehall Manufacturing Co · Model SP-1501-0001 · UDI-DI 00645724001072

IRQ
7
510(k) clearances
38
Adverse events
1
Recalls
48
Facilities

Description

FORMA-SPLINT-SP1501 CALIBRATED

Recalls

DateFirmReason
2011-11-15Biomet Microfixation, LLCOn 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled

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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.