Class 2 Device Recall Synthes

• Date Initiated by Firm: May 31, 2013
• Date Posted: July 17, 2013
• Recall Status: Terminated on August 31, 2015
• Recall Number: Z-1745-2013
• Recall Event ID: 65561
• 510(K)Number: K010690
• Product Classification: Screw, fixation, intraosseous - Product Code DZL
• Product: Multi Vector Distractor Pin Holding Clamp, limited bone stock; ; The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
• Code Information: Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.
• Recalling Firm/ Manufacturer: Synthes USA HQ, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Synthese Recall Information Center; 610-719-5000
• Manufacturer Reason for Recall: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there
• FDA Determined Cause: Device Design
• Action: Synthes sent a Urgent Notice: Medical Device Removal letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however, there is a remote potential that additional intervention would be required due to a non-functioning clamp. Synthes requested the product to be removed from inventory and returned to Synthes by calling 1-800-479-6329 to obtain a Return Authorization Number. Direct Accounts were asked to complete and return the Verification Section at the end of the letter indicating the quantity of affected product was found. Negative responses were also requested. If you have any questions please call (610) 719-5450.
• Quantity in Commerce: 121
• Distribution: US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
• 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 and Original Applicant = SYNTHES (USA)