Z-0639-2024Class II

Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

Name: Z-0639-2024 Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Creator: Zimmer Biomet Spine Inc.
Published: 2023-10-16
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2023-10-16 / Open, Classified / root cause: manufacturing process

FDA source

Zimmer Biomet Spine Inc. began a recall of Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System on 2023-10-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0639-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-16
Posted: 2024-01-04
Recalling firm: Highridge Medical, LLC
Product: Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/16/23, recall notices were sent to customers asking them to do the following: 1) Locate, quarantine, and return affected screws to the recalling firm. 2) Complete and return the inventory return certificate form via email to [email protected] Recall-related questions or concerns can be directed to please email [email protected].
Quantity in commerce: 3
Distribution: US Nationwide distribution in the states of MN, NE.
Product codes and lots: UDI-DI: 00889024002159, Lot: W834061

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0639-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0639-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-04

Product code NKB

K150896Class IIVitality Spinal Fixation SystemZimmer Spine, Inc. / cleared 2015-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)