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SPATIAL FRAME

Smith & Nephew, Inc. · Model 71935029 · UDI-DI 00885556469293

KTT Prescription
1
510(k) clearances
9,903
Adverse events (28 deaths)
89
Recalls
246
Facilities

Description

SPATIAL FRAME FULL RING 105MM BLUE

Recalls

DateFirmReason
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-06-10Orthofix U.S. LLCUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
2026-06-10Orthofix U.S. LLCUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
2026-06-10Orthofix U.S. LLCUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

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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.