Z-1253-2016Class II

10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230

Name: Z-1253-2016 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230
Creator: Biomet Spine, LLC
Published: 2016-02-12
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2016-02-12 / Terminated / root cause: labeling and UDI

FDA source

Biomet Spine, LLC began a recall of 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for... on 2016-02-12. FDA classified it as Class II and gives the reason as "Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1253-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Posted: 2016-03-25
Terminated: 2016-05-10
Recalling firm: Highridge Medical, LLC
Product: 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Zimmer Biomet sent an Urgent Medical Device Recall Notice letter dated February 26, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed Response Form. For questions call 303-465-8929.
Quantity in commerce: 10
Distribution: Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).
Product codes and lots: P/N1400-1230 from Lot#2350871 from either loose inventory or Kit 555000162, Date of Manufacture: April 16, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1253-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1253-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

Product code OVD

K081501Class IISolitaire Anterior Spinal SystemBiomet Spine / cleared 2008-07-02

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)