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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Spine Polaris Spinal System

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 Class 2 Device Recall Biomet Spine Polaris Spinal Systemsee related information
Date Initiated by FirmMarch 12, 2015
Date PostedJuly 20, 2015
Recall Status1 Terminated 3 on December 21, 2015
Recall NumberZ-2152-2015
Recall Event ID 70961
510(K)NumberK133746 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductPolaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
Code Information Part Numbers: 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230, 14-583235, 14-583240, 14-583245, 14-583250, 14-583320, 14-583325, 14-583330, 14-583335, 14-583340, 14-583345 and 14-583350. All lots.
Recalling Firm/
Manufacturer
Biomet Spine, LLC
399 Jefferson Rd
Parsippany NJ 07054-3707
For Additional Information ContactMr. Stephen Morey
303-501-8568
Manufacturer Reason
for Recall
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
FDA Determined
Cause 2
Nonconforming Material/Component
ActionBiomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.
Quantity in Commerce4,765 units
DistributionDistribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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