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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 2.4 VALCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right

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  Class 2 Device Recall Synthes 2.4 VALCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right see related information
Date Initiated by Firm July 30, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-2087-2013
Recall Event ID 65890
510(K)Number K083694  
Product Classification Plate, fixation, bone - Product Code HRS
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.
Code Information Part No. 02.111.730, with Lot No. 3614792
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Synthes Customer Service
610-719-5000
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action Synthes GMBH sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected product from stock. Customers were advised to complete the Verification Section at the end of the letter. For questions call 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in Commerce 11
Distribution USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
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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