Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1125-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: February 5, 2014

Date Posted: March 12, 2014

Recall Number: Z-1125-2014

Event ID: 67498

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).

Status: Terminated

Product Quantity: 45

Code Information:

part no. 02.231.240, lot no. 823111

Distribution Pattern:

Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.

Voluntary or Mandated:

Voluntary: Firm initiated