Class 2 Device Recall Altius MINI OCT Posterior Spinal Fixation System

• Date Initiated by Firm: March 16, 2017
• Create Date: March 28, 2017
• Recall Status: Terminated on July 30, 2018
• Recall Number: Z-1691-2017
• Recall Event ID: 76610
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• Product: Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
• Code Information: 505951,M16562R01,505951,510710,510981,514814,533566,536398,543663,546565,546566,549528,565465,565464,567525,
• Recalling Firm/ Manufacturer: Zimmer Biomet Spine, Inc; 310 Interlocken Pkwy; Suite 120; Broomfield CO 80021-3479
• For Additional Information Contact: Doug Myers; 303-443-7500
• Manufacturer Reason for Recall: Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
• FDA Determined Cause: Device Design
• Action: Zimmer Biomet sent an Urgent Medical Device Recall letter on March 20, 2017, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignee's Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. Prior to sending Altius Kits to central processing, perform a functional check of the driver withall screws in the kit to ensure they mate. If the drivers do not mate, please return in accordance with Step 3b. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form  Phase I. b. If the driver is unable to mate with the screws in the set, immediately sterilize and return the affected nonconforming product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form  Phase I and Attachment 2  Certificate of Sterilization to Zimmer Biomet. i. For each return, send a copy of Attachment 1 to jeremy.hansmann@zimmerbiomet.com ii. Include a hardcopy of Attachment 1 with your shipment for immediate processing. iii. Include a copy of Attachment 2  Certificate of Sterilization with returned instruments. iv. Mark the outside of the returns box(es) clearly with RECALL. 4. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that have the affected product. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 6. If
• Quantity in Commerce: 141
• Distribution: Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
• 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.