Recall Z-2231-2020 · NKB Thoracolumbosacral Pedicle Screw System
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - 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.
| Date | May 5, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root 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 hav |
| Quantity | 3235 total |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183550 | Vitality® Spinal Fixation System Zimmer Biomet Spine, Inc., Apr 8, 2019 |