Class 2 Device Recall Synthes TI MIRS Polyaxial Screw Body, Part Number 04.631.500

• Date Initiated by Firm: September 07, 2012
• Date Posted: November 26, 2013
• Recall Status: Terminated on December 18, 2015
• Recall Number: Z-0395-2014
• Recall Event ID: 63230
• 510(K)Number: K113044
• Product Classification: Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
• Product: Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
• Code Information: All lots
• 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: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
• FDA Determined Cause: Use error
• Action: Synthes sent an Urgent: Medical Device Product Removal letter on September 7, 2012, to all affected consignees. Consignees were requested to immediately cease using the product, examine their inventory and remove the parts from inventory. If they had the parts, they were further instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the verification section at the end of the letter and return the verification form. If they did not have the parts, they were requested to complete the verification section at the end of the letter and return the verification form. Consignees with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
• Quantity in Commerce: 757
• Distribution: Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
• 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 = NKB