FDA-Device2013-08-07Class II
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Synthes USA HQ, Inc.
Hazard
It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
Sold states
US Distribution including the states of CA, MN, NC and TN.
Affected count
8
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2013Don't want to check this manually?
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