Synthes 3.2 mm Guide Wire 400mm. Used for guiding the recall
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Why was Synthes 3.2 mm Guide Wire 400mm. Used for guiding the recalled?
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
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 No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.
- Product
- Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
- Recalling firm
- Synthes, Inc.
- Quantity
- 1,132,096
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
- Recall date
- February 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)