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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 2.4mm VALCP Two Column Volar Distal Radius Plate and Torque limiting Attachment, 1.2Nm

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  Class 2 Device Recall Synthes 2.4mm VALCP Two Column Volar Distal Radius Plate and Torque limiting Attachment, 1.2Nm see related information
Date Initiated by Firm May 31, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-2057-2013
Recall Event ID 65556
510(K)Number K071184  K083694  K092556  
Product Classification Plate, fixation, bone - Product Code HRS
Product Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm

Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Code Information Part number J8301-F
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Synthes Recall Information Center
610-719-6500
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 119, 891
Distribution Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
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