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U.S. Department of Health and Human Services

Class 2 Device Recall Solitaire Anterior Spinal System

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  Class 2 Device Recall Solitaire Anterior Spinal System see related information
Date Initiated by Firm February 12, 2016
Create Date March 25, 2016
Recall Status1 Terminated 3 on May 10, 2016
Recall Number Z-1253-2016
Recall Event ID 73402
510(K)Number K081501  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
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.
Code Information P/N1400-1230 from Lot#2350871 from either loose inventory or Kit 555000162, Date of Manufacture: April 16, 2013
Recalling Firm/
Manufacturer		 Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact
303-443-7500
Manufacturer 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.
FDA Determined
Cause 2		 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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OVD and Original Applicant = BIOMET SPINE
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