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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 1 of 500

Device	Model / Reference	Registries	Class	Status
Timberline Lateral Fusion System	8732-2120	FDA UDI	Class II	Active
Lineum® OCT	14-524720E	FDA UDI	Class II	Active
Vital™ MIS Spinal Fixation System	800M1021	FDA UDI	Class I	Active
Vital™	804M9000	FDA UDI	Class II	Active
Silverton-D® Deformity System	7718-7500	FDA UDI	Class II	Active
Vitality®	704M9010	FDA UDI	Class II	Active
Vitality®	705M7070	FDA UDI	Class II	Active
Vitality®	07.02015.014	FDA UDI	Class II	Active
C-Tek Maxan Anterior Cervical Plate System	14-521640B	FDA UDI	Class II	Active
Vital™	801M7035	FDA UDI	Class II	Active
Altius M-Ini Oct Spine Sys.	1200-0074	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8732-2416	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-581540	FDA UDI	Class II	Active
Lineum Oct Spine System	14-524007	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8708-4518	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8723-6016	FDA UDI	Class II	Active
Timberline Mpf Lateral Modular Plate Fixation System	8604-6010	FDA UDI	Class II	Active
Maxan One Anterior Cervical Plate System	14-522348E1	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	2000-7450E	FDA UDI	Class II	Active
Polaris(tm) 5.5 Spinal System	14-500597	FDA UDI	Class II	Active
Telluride® MIS Spinal Fixation System	7723-7525	FDA UDI	Class II	Active
Polaris 6.35 Ti Spinal System	14-515385	FDA UDI	Class II	Active
Spine System	8734-6117	FDA UDI	Class I	Active
Timberline Mpf Lateral Modular Plate Fixation System	8602-4514	FDA UDI	Class II	Active
Vitality®	706M4035	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-583860	FDA UDI	Class II	Active
Timberline Mpf Lateral Modular Plate Fixation System	8607-5535	FDA UDI	Class II	Active
Lineum® OCT Spine System	14-524144	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-500582	FDA UDI	Class II	Active
Polaris 4.75 Spinal System	14-563899	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	2000-4475	FDA UDI	Class II	Active
Vitality®	07.02000.039	FDA UDI	Class II	Active
Polaris 5.5 Ti Spinal System	14-578270	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-562722	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-573225	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-501297	FDA UDI	Class II	Active
Vail Oct Spinal Fixation System	7901-0100	FDA UDI	Class II	Active
Telluride Mis Spinal Fixation System	7723-9550	FDA UDI	Class II	Active
Concero™ Facet Screw System	7515-3545	FDA UDI	U	Active
Maxan One Anterior Cervical Plate System	14-522240E1	FDA UDI	Class II	Active
Silverton Spinal Fixation System	7727-7530	FDA UDI	Class II	Active
Silverton-D® Deformity System	7722-6500	FDA UDI	Class II	Active
Spinal Fixation System	7715-4540	FDA UDI	Class II	Active
Polaris 6.35 Spinal System	14-573285	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8714-6050	FDA UDI	Class II	Active
Vuelock® Anterior Cervical Plate System	63348	FDA UDI	Class II	Active
Lineum® OCT	14-524038E	FDA UDI	Class II	Active
Vitality®+ Osteotomy	733M1680	FDA UDI	Class I	Active
C-Tek Maxan Anterior Cervical Plate System	14-522268	FDA UDI	Class II	Active
Gallery™ Laminoplasty System	14-523228	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.