| Class 2 Device Recall Biomet Spine Polaris Spinal System |  |
Date Initiated by Firm | March 12, 2015 |
Date Posted | July 20, 2015 |
Recall Status1 |
Terminated 3 on December 21, 2015 |
Recall Number | Z-2152-2015 |
Recall Event ID |
70961 |
510(K)Number | K133746 |
Product Classification |
Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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Product | Polaris 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
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For Additional Information Contact | Mr. 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 |
Action | Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers. |
Quantity in Commerce | 4,765 units |
Distribution | Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NKB
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