Z-2318-2017Class II

Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs...

Name: Z-2318-2017 Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs...
Creator: Zimmer Biomet Spine Inc.
Published: 2017-05-10
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2017-05-10 / Terminated / root cause: design

FDA source

Zimmer Biomet Spine Inc. began a recall of Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017 on 2017-05-10. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2318-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-10
Posted: 2017-05-15
Terminated: 2018-05-25
Recalling firm: Highridge Medical, LLC
Product: Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
Product code: LYQ Accessories, Fixation, Spinal Intervertebral Body
Reason for recall: Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees will be notified on 5/15/17 via certified mail to return products.
Quantity in commerce: 497 units
Distribution: Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Product codes and lots: Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2318-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2318-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-08

Product code LYQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)