Device product
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.
Z-1816-2013
Product summary
- Event
- Event 65669
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-1816-2013
Official wording
Reason: 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.
Code information: Part Number 390.007, Lot Number 6800599
Distribution pattern: US Distribution including the states of CA, MN, NC and TN.
Derived failure modes
-
Unknown
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.