Synthes Large External Fixation recall
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is…
Why was Synthes Large External Fixation recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 390.007, Lot Number 6800599
- Product
- Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 8
- Distribution
- US Distribution including the states of CA, MN, NC and TN.
- Recall date
- August 7, 2013
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)