🔍 RecallPedia

Biomet Spine

14 recalls •
🏥 Medical Devices
• Categories: Infusion Pumps, Other Medical Devices, Surgical Instruments, Implants & Prosthetics

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 in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Class I - Dangerous

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.

Feb 12, 2016 Infusion Pumps Nationwide View Details →

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 spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

Class I - Dangerous

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.

Jul 22, 2015 Surgical Instruments Nationwide View Details →

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.

Class I - Dangerous

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 Other Medical Devices Nationwide View Details →

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 the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Class I - Dangerous

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

Nov 30, 2012 Implants & Prosthetics Nationwide View Details →

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 the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

Class I - Dangerous

Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.

Feb 22, 2012 Surgical Instruments View Details →

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 quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.

Class I - Dangerous

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.

Dec 19, 2011 Surgical Instruments View Details →

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 Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

Class I - Dangerous

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 Surgical Instruments View Details →

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.

Class I - Dangerous

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.

Aug 22, 2013 Other Medical Devices View Details →

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 to anchor the plate to the vertebrae.

Class I - Dangerous

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 Other Medical Devices View Details →

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 two contiguous spinal levels from L2S1.

Class I - Dangerous

Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.

Mar 9, 2011 Implants & Prosthetics Nationwide View Details →