FDAFDA · Food and drugs·Recall number Z-1816-2013
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.
Published August 7, 2013 · Recall initiated: October 12, 2012
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- US Distribution including the states of CA, MN, NC and TN.
- Lot
- Part Number 390.007, Lot Number 6800599
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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