Helical Blade Inserter for Trochanteric Fixation recall
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent…
Why was Helical Blade Inserter for Trochanteric Fixation recalled?
The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
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 Lot Numbers 03.037.024 T102759
- Product
- Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 32
- Distribution
- Nationwide Distribution.
- Recall date
- July 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)