Titanium Low Profile Neuro Screw recall
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended…
Why was Titanium Low Profile Neuro Screw recalled?
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
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?
Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875
- Product
- Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 500 units distributed in USA, and 35 units distributed OUS
- Distribution
- Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland.
- Recall date
- April 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)