Class 2 Device Recall Vital MIS Spinal Fixation system

• Date Initiated by Firm: May 05, 2020
• Create Date: June 02, 2020
• Recall Status: Terminated on July 15, 2022
• Recall Number: Z-2219-2020
• Recall Event ID: 85613
• 510(K)Number: K183550
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.
• Code Information: UDI: (01)00887868324840; Lot Numbers: C19H0013 C19I0009 C19J0009 C19K0010 C20A0003 SBM108408 SBM118990
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• Manufacturer Reason for Recall: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
• FDA Determined Cause: Under Investigation by firm
• Action: URGENT MEDICAL DEVICE RECALL notification letters dated 5/5/20 were sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-447-3625 between 8:00 am and 6:00pm MST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. Patients should continue with the post-operative care as scheduled by their surgeon who typically assess the construct as part of their evaluation(s). During these visits, surgeons should compare follow up radiographs to the immediate post-op radiographs to determine if the Closure Tops have loosened. Additionally, consider doing dynamic imaging such as flexion/extension to detect implant movement when appropriate. If Closure Top loosening and/or migration is noted, surgeon may consider surgical intervention. During this surgical intervention, consideration should be made regarding replacement of the closure tops as well as the screws. 3. Complete Attachment 1  Certificate of Ackn
• Quantity in Commerce: 3235 total
• Distribution: US nationwide distribution.
• 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