FDA recall Z-0867-2019

Zimmer Biomet Spine Inc. · Class II · device

Product

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 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 manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.

Reason for recall

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.

Key facts

Status
Terminated
Initiation date
2018-07-30
Report date
2019-03-06
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westminster, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0867-2019