Westminster, CO, United States
Zimmer Biomet Spine Inc. recalls
2 recalls recorded since 2018, most recently on 16 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 October 2023
- Reason
- Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
- Distribution
- US Nationwide distribution in the states of MN, NE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0639-2024
- Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Terminated Class II Medical devices
- Recall started
- 30 July 2018
- Terminated
- 28 April 2021
- 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
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0868-2019, Z-0866-2019, Z-0867-2019
- 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 medic
- Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical speci
- Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical spe
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.