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

• Date Initiated by Firm: July 30, 2013
• Date Posted: November 27, 2013
• Recall Status: Terminated 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: 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