Device Recall Synthes 2.4mm VALCP Two Column Volar Distal Radius Plate and Torque limiting Attachment, 1.2Nm 의 리콜

Recall

65556

Class 2

Z-2057-2013

2013-05-31

2013-08-26

Terminated

United States

2015-09-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119565

The firm is initiating a field safety correction for the labeling of the 2.4mm va-lcp two column volar distal radius plate and 1.2 nm torque limiting attachment. the us technique guide lists 1.2nm tla as an option for use with the 2.4mm variable angle lcp (va-lcp) two-column (standard & narrow) volar distal radius plate. the potential exists for the va locking screw to be driven through the 2.4mm.

Synthes sent an Urgent Notice: Medical Device Labeling Correction letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm VA-LCP Two Column Volar Distal Radius Plate when used with a 1.2Nm Torque Limiting Attachment. A screw that passes through the VA-LCP plate is not likely to result in a serious adverse event although should it occur, additional medical intervention during the index procedure could be needed. If you have any questions, please call (610) 719-5450, or contact your Synthes sales Consultant.