Class 3 Device Recall Erisma LP posterior fixation system

• Date Initiated by Firm: July 01, 2019
• Create Date: July 18, 2019
• Recall Status: Terminated on July 09, 2020
• Recall Number: Z-1986-2019
• Recall Event ID: 83218
• 510(K)Number: K153326
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: Erisma- LP posterior fixation system with the below specifically affected products: ; ; 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); ; ; 2. Erisma-LP Screwdriver; ; ; 3. Erisma-LP T20 Wrench; ; ; 4. Erisma-LPT20 Snap Fit Tightening Wrench
• Code Information: 1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001
• Recalling Firm/ Manufacturer: Clariance Inc; 4809 N Ravenswood Ave Unit 119; Chicago IL 60640-4417
• For Additional Information Contact: Sylvain Chambat; 773-868-7041
• Manufacturer Reason for Recall: Potential for the polyaxial screw to become disassembled during implant.
• FDA Determined Cause: Use error
• Action: Clariance, Inc. notified customers on about 07/01/2019 via "MEDICAL DEVICE FIELD SAFETY NOTICE - SN20190603". Customers were informed that when using the 18710024 Screwdriver, the user should ensure that the tip of the screwdriver is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement, the user is able to fully connect the screwdriver on the screw head. Disassembly of the polyaxial screw can occur when the 18710024 Screwdriver is not fully inserted and threaded into the screw head. Additionally when using the 18720000T20 Wrench or 01720001 T20 Snap Fit Tightening Wrench, the user should ensure that the tip of the T20 Wrench or the T20 Snap Fit Tightening Wrench is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement the user is able to adjust the insertion depth of the polyaxial screw. Customers were instructed to read the Field Safety Notice carefully, review the revised Surgical Techniques Guide provided as Attachment A that include in Section 2, Insertion of Pedicle Screws, enhanced instructions to help ensure that the user properly uses the 18710024 Screwdriver, the 18720000T20 Wrench, or the 01720001 T20 Snap Fit Tightening Wrench with the Erisma-LP polyaxial screws, in order to help reduce the possibility of disassembly. They were also instructed to replace the existing Surgical Techniques Guide(s) within your files with the revised Surgical Techniques Guide and to complete and return the response card, Attachment B. Questions can be directed to Clariance via telephone 773-868-7041, or your local sales representative.
• Quantity in Commerce: 4,090 units distributed in the US
• Distribution: Nationwide distribution to CA, IL, IN, NY, OH, TX.
• 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 and Original Applicant = CLARIANCE, SAS