Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The recall
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of…
Why was Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The recalled?
The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
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 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.
- Product
- Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of…
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 333 screws
- Distribution
- Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.
- Recall date
- September 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)