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U.S. Department of Health and Human Services

Class 2 Device Recall LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong

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  Class 2 Device Recall LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong see related information
Date Initiated by Firm December 05, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on February 13, 2007
Recall Number Z-0489-2007
Recall Event ID 37010
510(K)Number K012114  
Product Classification bone fixation plate - Product Code HRS
Product LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
Code Information Catalog number 242.465, Lot number 5373486
Recalling Firm/
Manufacturer		 Synthes
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Scott Eden
800-620-7025
Manufacturer Reason
for Recall		 Hole is malformed, leading to reduced construct strength.
FDA Determined
Cause 2		 Other
Action All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.
Quantity in Commerce 11 units
Distribution The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.
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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