Intervertebral Fusion Device With Bone Graft, Lumbar

Medicrea, IB3D Universal Implant Inserter, Rx Only

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Medicrea, IB3D PL Instruments Set, Rx Only

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Brand Name: FORZA" PTC Spacer System

Labeling contains claims that are not consistently present.

Brand Name: Forza" Ti Spacer System

Labeling contains claims that are not consistently present.

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers:

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:

The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

Calibrate CCX Interbody System for spinal fusion procedures:

Complaints have been received regarding post-operative implant collapse.

TxHA PEEK IBF/TxTiHA IBF System REF BTA-151

Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.