Class 2 Device Recall Low Profile U Joint Driver for the SynFix Mini Open System

• Date Initiated by Firm: November 20, 2008
• Date Posted: January 30, 2009
• Recall Status: Terminated on October 27, 2009
• Recall Number: Z-0931-2009
• Recall Event ID: 50523
• 510(K)Number: K072253
• Product Classification: Lumbar Intervertebral Fusion Device with Bone Graft - Product Code MAX
• Product: Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.
• Code Information: Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244.
• FEI Number: 3005180112
• Recalling Firm/ Manufacturer: Synthes Spine; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Lynne Lewis BSN RN; 610-719-5000
• Manufacturer Reason for Recall: screwdriver tip may break off and lodge in the screw head
• FDA Determined Cause: Device Design
• Action: The recalling firm emailed all Spine Sales Consultants on 11/20/08. They were instructed to immediately examine their stock and discuss appropriate technique with surgeon users. In addition, a Medical Device Correction letter dated 11/19/08 was issued via USPS certified mail to the medical facilities. This initial letter stated the issue and requested the users take the following actions: discard all SynFix Technique Guides and replace with the updated literature contained in the mailing packet with the letter, and is identified by code J7022-E (Rev. E); to ensure receipt and understanding of the information, the Verification Section of the letter needs to be completed and returned to Synthes by either fax: 610-719-5120 or scan/e-mail: lewis.lynne@synthes.com. An Urgent: Medical Device Recall letter, dated 1/16/2009, was also sent out. This latter letter requested that users examine their stock immediately and remove any of the affected devices from their inventory. Customers are also to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the Verification Section; and return the letter with the recalled product to the address listed. There are also actions for those who do not have the affected product. Questions should be directed to 800-620-7025 x 5453 or 610-719-5453.
• Quantity in Commerce: 381 units
• Distribution: Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.
• 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 = MAX