Biomet Spine, LLC

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1253-2016Class II10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. February 12, 2016
Z-0203-2016Class IIMaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn AnteSeptember 29, 2015
Z-2744-2015Class IIBiomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. LoAugust 5, 2015
Z-2759-2015Class IIBiomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 anJuly 22, 2015
Z-2152-2015Class IIPolaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, RMarch 12, 2015
Z-1466-2015Class IITorque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterioMarch 12, 2015
Z-1465-2015Class IILineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to faciliMarch 12, 2015
Z-0982-2015Class IIAnchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. TimberlineAugust 22, 2013
Z-0978-2015Class IITimberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 August 22, 2013
Z-0983-2015Class IITimberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored LaterAugust 22, 2013
Z-1146-2015Class IISet Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to sNovember 30, 2012
Z-1069-2015Class IITimberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusablFebruary 22, 2012
Z-1089-2015Class IITelluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device proviDecember 19, 2011
Z-0220-2015Class IILANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage:March 9, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K152622Alta ACDF SystemJuly 8, 2016
K153695Biomet Spine Fusion SystemJanuary 21, 2016
K151974Polaris Spinal SystemNovember 13, 2015
K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small IntervertebralAugust 12, 2015
K151483Biomet Spine Fusion SystemJuly 31, 2015
K151224Lineum OCT Spine SystemJune 30, 2015
K142634Biomet Spine Fusion SystemMarch 12, 2015
K141791BIOMET FUSION SYSTEMOctober 9, 2014
K141804POLARIS SPINAL SYSTEM - HA COATEDSeptember 25, 2014
K121130POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSJune 15, 2012
K112014ZYSTON STRAIGHT SPACER SYSTEMOctober 17, 2011
K103393POLARIS SPINAL SYSTEMFebruary 2, 2011
K093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMMarch 9, 2010
K0910675.5 POLARIS SPINAL SYSTEMJuly 14, 2009
K082793INTERGRO DBMApril 2, 2009
K081952SYNERGY SPINAL SYSTEM (6.35 POLARIS)October 7, 2008
K081636PEEK-OPTIMA ALIF SPACERAugust 7, 2008
K081501SOLITAIRE ANTERIOR SPINAL SYSTEMJuly 2, 2008
K081395SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEMJune 25, 2008
K080646C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEMMay 2, 2008