Recall Z-1691-2017 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Zimmer Biomet Spine, Inc
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); spondylolist
| Date | Mar 16, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 141 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.