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Recall Observatory FDA recall evidence

Device product

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.

Z-1125-2014

February 05, 2014

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 67498
Status
Terminated
Classification
Class II
Quantity
45
Official record key
device-enforcement:Z-1125-2014

Official wording

Reason: 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).

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).