Recall Z-0866-2019— Zimmer Biomet Spine Inc.

Name: FDA recall Z-0866-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-30

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet Spine Inc., initiated 2018-07-30, terminated 2021-04-28. It names 2 FDA 510(k) clearances: K171907, K150896. Product: 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 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: 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.

Recalling firm: Zimmer Biomet Spine Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-30
Terminated: 2021-04-28
Firm location: Westminster, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K171907 — Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.·cleared 2017-07-14
K150896 — Vitality Spinal Fixation SystemZimmer Spine, Inc.·cleared 2015-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.