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Recall Observatory FDA recall evidence

Device product

Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

Z-0409-2014

July 30, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66418
Status
Terminated
Classification
Class II
Quantity
13
Official record key
device-enforcement:Z-0409-2014

Official wording

Reason: The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

Code information: Part No. 02.001.324, lot no. 6900823

Distribution pattern: Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.