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Biomet Spine, LLC

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The recall (Z-0203-2016)Biomet Spine, LLC2015-11-03
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14 recall (Z-2759-2015)Biomet Spine, LLC2015-09-10
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate S recall (Z-2744-2015)Biomet Spine, LLC2015-09-09
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non- recall (Z-2152-2015)Biomet Spine, LLC2015-07-20
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to recall (Z-1465-2015)Biomet Spine, LLC2015-04-20
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides post recall (Z-1466-2015)Biomet Spine, LLC2015-04-20
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is us recall (Z-1146-2015)Biomet Spine, LLC2015-02-24
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable dev recall (Z-1089-2015)Biomet Spine, LLC2015-02-11
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is recall (Z-1069-2015)Biomet Spine, LLC2015-02-09
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timb recall (Z-0982-2015)Biomet Spine, LLC2015-01-15
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Ancho recall (Z-0983-2015)Biomet Spine, LLC2015-01-15
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 8630 recall (Z-0978-2015)Biomet Spine, LLC2015-01-14
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product recall (Z-0220-2015)Biomet Spine LLC.2014-12-16

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Every clearance here is in the API, with alerts when new ones post.