Class 2 Device Recall Synthes MultiVector Distractor Body, Part Number 487.931

• Date Initiated by Firm: January 11, 2013
• Date Posted: March 01, 2013
• Recall Status: Terminated on August 31, 2015
• Recall Number: Z-0903-2013
• Recall Event ID: 64195
• 510(K)Number: K010690
• Product Classification: Screw, fixation, intraosseous - Product Code DZL
• Product: Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
• Code Information: Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
• FEI Number: 3005180112
• Recalling Firm/ Manufacturer: Synthes USA HQ, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: customer support; 610-719-5000
• Manufacturer Reason for Recall: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
• FDA Determined Cause: Device Design
• Action: The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
• Quantity in Commerce: 2
• Distribution: Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
• 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 = DZL