Recall Z-0401-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0401-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-05-29, terminated 2015-05-21. It names one FDA 510(k) clearance: K110354. Product: Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.. Reason: A plate was inadvertently released to a sales consultant that was restricted for sale..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-29
Terminated: 2015-05-21
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K110354 — 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEMSynthes USA·cleared 2011-03-04

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 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

Reason for recall

A plate was inadvertently released to a sales consultant that was restricted for sale.

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