Intervertebral Fusion Device With Bone Graft, Cervical

Brand Name: CONSTRUX" Mini PTC Spacer System

Labeling contains claims that are not consistently present.

Brand Name: CONSTRUX" Mini Ti Spacer System

Labeling contains claims that are not consistently present.

IMPIX MANTA, REF numbers:

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

IMPIX C+, REF numbers:

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

IMPIX MANTA+, REF numbers:

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

C-Plus" 10mm x 12mm Webless implants

As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s

SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage)

The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

Octane-C Cervical, 6 Lordotic

Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year

Synthes Spine Zero-P Instruments and Implants.

LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.

Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.

Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.