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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 2.4 mm LCDCP Plate 6 Holes/51mm

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  Class 2 Device Recall Synthes 2.4 mm LCDCP Plate 6 Holes/51mm see related information
Date Initiated by Firm July 30, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on August 17, 2015
Recall Number Z-0406-2014
Recall Event ID 66413
510(K)Number K001941  
Product Classification Plate, fixation, bone - Product Code HRS
Product Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm

Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
Code Information Part No. 249.926, lot No. 8093100
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer Reason
for Recall		 A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.
FDA Determined
Cause 2		 Labeling mix-ups
Action Synthes 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, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
Quantity in Commerce 13
Distribution Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally 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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