Synthes

One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.

There is a potential for the connection screw of the stem extractor to break.

May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.

It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.

A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).

Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.

affected parts and lots of the Cannulated Drill Bits have the potential to break during use

TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.

The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.

For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site.

The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.

Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.

Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.

Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.

Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.

The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.

Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the i

DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.

A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.

The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.

All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.

Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.

The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.

The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.

The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.

Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.

Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).

One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.

Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.