Screw, Fixation, Bone

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

The cannulation of the CCS screw is not centered.

I.T.S. Screw System with the below descriptions and corresponding article numbers.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Brand Name: APTUS

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

Brand Name: APTUS

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Removal of affected lot of screws due to labeling error.

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Screw is 16mm long instead of 22mm long.

TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only

Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only

Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and sta

Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention