Recall Z-0409-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0409-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-30

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-07-30, terminated 2015-08-31. It names one FDA 510(k) clearance: K041911. Product: Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.. 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..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K041911 — SYNTHES (USA) LCP CURVED PLATESSynthes (Usa)·cleared 2004-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.