Cerclage, Fixation

Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or frac

Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.

Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fractu

The end cap may loosen and detach making the instrument non-functional. No injuries reported.

Medical Device Exchange 3.5mm Threaded Cerclage Pin;

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile.

The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.

Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile.

Lack of Sterility Assurance

Synthes Application Instrument Sternal Zip Flex System

When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.

CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith &

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.

CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith &

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.

Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805.

The outer package is properly labeled, but the inner package may be labeled as a femoral component.

Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885

Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.