Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
Class I - DangerousWhat Should You Do?
- Check if you have this product: part no. 02.231.240, lot no. 823111
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synthes, Inc.
- Reason for Recall:
- Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
Product Codes/Lot Numbers:
part no. 02.231.240, lot no. 823111
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1125-2014
Related Recalls
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.