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FDAFDA · Food and drugs·Recall number Z-2087-2013

Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

Published September 4, 2013 · Recall initiated: July 30, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Synthes USA HQ, Inc.
Distributor
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Lot
Part No. 02.111.730, with Lot No. 3614792
Risk classification
Class II
Area (FDA)
device
Country
United States

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