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Response Spine System

ORTHOPEDIATRICS CORP. · Model 01-1600-5590 · UDI-DI 00840194498968

MDI Prescription
2
510(k) clearances
1,052
Adverse events (15 deaths)
1
Recalls
5
Facilities

Description

Response Modular Counter Torque, Rib Clamp

Recalls

DateFirmReason
2015-07-29Synthes (USA) Products LLCThe last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the

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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.