Synthes External Fixation System Tube to Tube Clamp recall
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures…
Why was Synthes External Fixation System Tube to Tube Clamp recalled?
The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 8
- Distribution
- Nationwide Distribution-including the states of CA, MN, NC, and TN.
- Recall date
- November 21, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)