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Synthes GmbH · Model 245.06 · UDI-DI 10886982169587

KTWKWP Prescription
10
510(k) clearances
910
Adverse events
57
Recalls
51
Facilities

Description

3.5MM RECONSTRUCTION PLATE 16 HOLES/190MM

Recalls

DateFirmReason
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.

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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.