Recall Z-2087-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-2087-2013
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 2015-05-21. It names one FDA 510(k) clearance: K083694. Product: 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.. Reason: 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..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Terminated: 2015-05-21
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K083694 — SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATESSynthes (Usa)·cleared 2009-03-06

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 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.

Reason for recall

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.

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