Manufacturer

Biomet Spine, LLC

14 recalls in our database name Biomet Spine, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 14
Critical: 0
Severe: 2
Most recent: 2016-04-06

Of the 14 recalls from Biomet Spine, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

ModerateFDA (Devices)·Z-1253-2016·2016-04-06
Biomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle
Biomet Spine is recalling specific Solitaire Ti Spacers because they are mislabeled as having a 12-degree lordotic angle when the actual angle is 6 degrees.
Product
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0203-2016·2015-11-11
Biomet Spine Recalls MaxAn Cervical Spine Screws Due to Labeling Error
Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.
Product
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2759-2015·2015-09-16
Biomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues
Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.
Product
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2744-2015·2015-09-16
Biomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall
Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.
Product
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2015·2015-07-29
Biomet Polaris 4.75 TI Spinal System Multiaxial Screws Recalled for Fatigue Strength
Biomet Spine is recalling 4,765 units of Polaris 4.75 TI Spinal System multiaxial screws because they may not meet internal fatigue strength requirements.
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1465-2015·2015-04-29
Biomet Recalls Lineum HF Torque Handle Limit Due to Component Updates
Biomet Spine is recalling 148 Lineum HF Torque Handle Limit units because the supplier withdrew the product for component updates or reconfiguration.
Product
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1466-2015·2015-04-29
Biomet Recalls Torque Limiting Handles for Spinal Fixation Devices
Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.
Product
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1146-2015·2015-03-04
Biomet Spine Recalls Out-of-Specification 5.5 mm Rod Set Screws
Biomet Spine is recalling 1,999 5.5 mm rod set screws because they are out of specification. The devices are used in spinal fixation constructs.
Product
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1089-2015·2015-02-18
Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect
Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during surgery.
Product
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1069-2015·2015-02-18
Biomet Spine Recalls Timberline Cranial Caudal and Posterior Blades
Biomet Spine, LLC is recalling Timberline Cranial Caudal and Posterior Blades due to an oversize set screw hex feature.
Product
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0978-2015·2015-01-21
Biomet Timberline Anchored Lateral Variable Retractable Sleeves Recalled for Undersized Diameter
Biomet Spine is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves because the inner diameter is undersized, causing interference fit issues.
Product
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized t
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0982-2015·2015-01-21
Biomet Spine Recalls Anchored Lateral Retractable Drills Due to Sizing Defect
Biomet Spine is recalling 15 Anchored Lateral Retractable Drills because the shaft diameter is oversized, causing interference when inserted into sleeve assemblies.
Product
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0983-2015·2015-01-21
Biomet Spine Recalls Timberline Anchored Lateral Fixed Retractable Sleeves
Biomet Spine is recalling 14 Timberline Anchored Lateral Fixed Retractable Sleeves because the inner diameter is undersized, causing interference fit when inserting instruments.
Product
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The T
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0220-2015·2014-11-26
Biomet Spine Recalls Durango Anchored ALIF Plate Due to Set Screw Risk
Biomet Spine is voluntarily recalling 120 Durango Anchored ALIF Plate units because the set screw component may become dislodged from the plate assembly.
Product
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or tw
Category
Medical Device
Distribution
Distributed nationwide