Nakoma-SL Anterior Cervical Plating System's Variable recall
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior…
Why was Nakoma-SL Anterior Cervical Plating System's Variable recalled?
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
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?
Lot numbers SM59161 and SM60278
- Product
- Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior…
- Recalling firm
- Alliance Partners LLC
- Quantity
- 21 units
- Distribution
- US Nationwide Distribution in the states LA, TX, and PR.
- Recall date
- July 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)