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BIOMET SPINE LLC

Last updated May 24, 2026

Information

Country: US
Address: —
Website: zimmerbiomet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)447-3625
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 018577570

Catalogue (32639)

Page 2 of 500

Device	Model / Reference	Registries	Class	Status
Polaris™ 6.35 Spinal System	14-575168	FDA UDI	Class II	Active
Polaris 4.75 Spinal System	14-563370	FDA UDI	Class II	Active
Solitaire-C Cervical Spacer Sys	14-531716E	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	2000-5345	FDA UDI	Class II	Active
Vitality®	705M7060	FDA UDI	Class II	Active
Vitality®	702M9560	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	14-503780	FDA UDI	Class II	Active
Polaris 4.75 Spinal System	14-563991	FDA UDI	Class II	Active
Array® Spinal System	94070J	FDA UDI	Class II	Active
Virage®	07.01717.003	FDA UDI	Class II	Active
Polaris 5.5 Sst Spine Sys	14-506435	FDA UDI	Class II	Active
Silverton-D Deformity System	7717-4530	FDA UDI	Class II	Active
Lineum® OCT Spine System	14-524058	FDA UDI	Class II	Active
Ballista® Percutaneous	14-500645E	FDA UDI	Class II	Active
Vitality®	07.02015.024	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-586420T	FDA UDI	Class II	Active
Vail Oct Spinal Fixation System	7907-0060	FDA UDI	Class II	Active
Vital™	815M4160	FDA UDI	Class II	Active
Vital™	801M4545	FDA UDI	Class II	Active
Telluride® 2 MIS Spinal Fixation System	7740-6525	FDA UDI	Class II	Active
Silverton-D® Deformity System	7739-4555	FDA UDI	Class II	Active
Silverton-D® Deformity System	7722-7595	FDA UDI	Class II	Active
Zyston Straight Spacer Sys	14-534054	FDA UDI	Class II	Active
C-Tek® Anterior Cervical Plate Sys	1100-2114B	FDA UDI	Class II	Active
C-Tek® Anterior Cervical Plate Sys	1100-0494T	FDA UDI	Class II	Active
Array Spinal System	94040J	FDA UDI	Class II	Active
Zyston Straight Spacer Sys	14-534097	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	2000-4855	FDA UDI	Class II	Active
Polaris 5.5 Spine System	2000-1035	FDA UDI	Class II	Active
Timberline Mpf Lateral Modular Plate Fixation System	8620-5014	FDA UDI	Class II	Active
Lineum® OCT	14-524722E	FDA UDI	Class II	Active
Timberline Mpf Lateral Modular Plate Fixation System	8603-4012	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8714-4530	FDA UDI	Class II	Active
Spine System	LV00238	FDA UDI	Class II	Active
Polaris 4.75 Spinal System	14-562395	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	2000-4230	FDA UDI	Class II	Active
Silverton-D® Deformity System	7736-8550	FDA UDI	Class II	Active
Zyston® Straight Interbody Fusion System	14-534775	FDA UDI	Class II	Active
Vital™	815M3090	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8724-4512	FDA UDI	Class II	Active
Breckenridge Intervertebral Body/Vbr Fusion System	8824-4707	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8703-3512	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-584799	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	2000-4250	FDA UDI	Class II	Active
C-THRU™ Anterior Spinal System	14-531171	FDA UDI	Class II	Active
Zyston® Straight Interbody Fusion System	14-534595	FDA UDI	Class II	Active
MaxAn® Anterior Cervical	14-522228E	FDA UDI	Class II	Active
Lineum® Oct Spine System	14-524422	FDA UDI	Class II	Active
Timberline Lateral Fusion	8725-4510	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-581660L	FDA UDI	Class II	Active

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 12, 2016	Z-1253-2016	—	terminated	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.
Sep 29, 2015	Z-0203-2016	—	terminated	The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Aug 5, 2015	Z-2744-2015	—	terminated	Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
Jul 22, 2015	Z-2759-2015	—	terminated	Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Mar 12, 2015	Z-1465-2015	—	terminated	Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Mar 12, 2015	Z-1466-2015	—	terminated	Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Mar 12, 2015	Z-2152-2015	—	terminated	Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Aug 22, 2013	Z-0983-2015	—	terminated	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve.
Aug 22, 2013	Z-0978-2015	—	terminated	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
Aug 22, 2013	Z-0982-2015	—	terminated	The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
Nov 30, 2012	Z-1146-2015	—	terminated	Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Feb 22, 2012	Z-1069-2015	—	terminated	Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.
Dec 19, 2011	Z-1089-2015	—	terminated	The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
Mar 9, 2011	Z-0220-2015	—	terminated	Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.