Recall Z-0868-2019 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Zimmer Biomet Spine Inc.
Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufac
| Date | Feb 22, 2019 (initiated Jul 30, 2018) |
| Status | Terminated |
| Reason | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications |
| Root cause | Nonconforming Material/Component |
| Action | On August 30, 2018 a Urgent Medical Recall notification letter was sent to Distributors and Hospital Risk Managers notifying them of the Zimmer Biomet Vitality Shear-off Set Screw recall. The notification letter described the potential risks associated to the recall and steps they needed to follow to mitigate those potential risk. The responisbilities as described by Zimmer Biomet to the customers is as follows: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your invent |
| Quantity | 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliance |
| Distribution | Distributed Nationwide: AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA and WI.**** International distribution: Australia and EMEA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150896 | Vitality Spinal Fixation System Zimmer Spine, Inc., Aug 31, 2015 |