Class 2 Device Recall Radiolucent Retractor for Upper Cervical Spine

• Date Initiated by Firm: October 02, 2014
• Date Posted: October 20, 2014
• Recall Status: Terminated on December 18, 2015
• Recall Number: Z-0092-2015
• Recall Event ID: 69432
• Product Classification: Retractor - Product Code GAD
• Product: DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
• Code Information: Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
• Recalling Firm/ Manufacturer: Synthes, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Customer Support; 610-719-5000
• Manufacturer Reason for Recall: Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
• FDA Determined Cause: Material/Component Contamination
• Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated October 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or " Scan/email: Fieldaction@synthes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by Fax: (610) 430-7083 or Scan/email: Fieldaction@sythes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant. Thank you for your attention to this issue.
• Quantity in Commerce: 11
• Distribution: US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
• 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.