Guide, Surgical, Instrument（FZX）

Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Potential failure of sterile packaging seal.

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.

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.

DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay.

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi

Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.

The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

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.

There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.

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.

Revision B of the tissue shields of the device was 7 mm longer than the previous design.

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.