NRAC Issue #1574 ADDENDUM April 19, 2006 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. ----------------------------------------------------------------------------- PRODUCT a) METRx II Tube, 14mm x 3cm stainless steel tubular retractor, Part No. 9569660 RECALL NUMBER # Z-0719-06; PRODUCT b) METRx II Tube, 14mm x 4cm stainless steel tubular retractor, Part No. 9569661 RECALL NUMBER # Z-0720-06; PRODUCT c) METRx II Tube, 14mm x 5cm stainless steel tubular retractor, Part No. 9569662 RECALL NUMBER # Z-0721-06; PRODUCT d) METRx II Tube, 14mm x 6cm stainless steel tubular retractor, Part No. 9569663 RECALL NUMBER # Z-0722-06; PRODUCT e) METRx II Tube, 14mm x 7cm stainless steel tubular retractor, Part No. 9569664 RECALL NUMBER # Z-0723-06; PRODUCT f) METRx II Tube, 14mm x 8cm stainless steel tubular retractor, Part No. 9569665 RECALL NUMBER # Z-0724-06; PRODUCT g) METRx II Tube, 14mm x 9cm stainless steel tubular retractor, Part No. 9569666 RECALL NUMBER # Z-0725-06; PRODUCT h) METRx II Tube, 16mm x 3cm stainless steel tubular retractor, Part No. 9569670 RECALL NUMBER # Z-0726-06; PRODUCT i) METRx II Tube, 16mm x 4cm stainless steel tubular retractor, Part No. 9569671 RECALL NUMBER # Z-0727-06; PRODUCT j) METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672 RECALL NUMBER # Z-0728-06; PRODUCT k) METRx II Tube, 16mm x 6cm stainless steel tubular retractor, Part No. 9569673 RECALL NUMBER # Z-0729-06; PRODUCT l) METRx II Tube, 16mm x 7cm stainless steel tubular retractor, Part No. 9569674 RECALL NUMBER # Z-0730-06; PRODUCT m) METRx II Tube, 16mm x 8cm stainless steel tubular retractor, Part No. 9569675 RECALL NUMBER # Z-0731-06; PRODUCT n) METRx II Tube, 16mm x 9cm stainless steel tubular retractor, Part No. 9569676 RECALL NUMBER # Z-0732-06; PRODUCT o) METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680 RECALL NUMBER # Z-0733-06; PRODUCT p) METRx II Tube, 18mm x 4cm stainless steel tubular retractor, Part No. 9569681 RECALL NUMBER # Z-0734-06; PROUDCT q) METRx II Tube, 18mm x 5cm stainless steel tubular retractor, Part No. 9569682 RECALL NUMBER # Z-0735-06; PRODUCT r) METRx II Tube, 18mm x 6cm stainless steel tubular retractor, Part No. 9569683 RECALL NUMBER # Z-0736-06; PRODUCT s) METRx II Tube, 18mm x 7cm stainless steel tubular retractor, Part No. 9569684 RECALL NUMBER # Z-0737-06; PRODUCT t) METRx II Tube, 18mm x 8cm stainless steel tubular retractor, Part No. 9569685 RECALL NUMBER # Z-0738-06; PRODUCT u) METRx II Tube, 18mm x 9cm stainless steel tubular retractor, Part No. 9569686 RECALL NUMBER # Z-0739-06; PRODUCT v) METRx II Tube, 20mm x 3cm stainless steel tubular retractor, Part No. 9569720 RECALL NUMBER # Z-0740-06; PRODUCT w) METRx II Tube, 20mm x 4cm stainless steel tubular retractor, Part No. 9569721 RECALL NUMBER # Z-0741-06; PRODUCT x) METRx II Tube, 20mm x 5cm stainless steel tubular retractor, Part No. 9569722 RECALL NUMBER # Z-0742-06; PRODUCT y) METRx II Tube, 20mm x 6cm stainless steel tubular retractor, Part No. 9569723 RECALL NUMBER # Z-0743-06; PRODUCT z) METRx II Tube, 20mm x 7cm stainless steel tubular retractor, Part No. 9569724 RECALL NUMBER # Z-0744-06; PRODUCT aa) METRx II Tube, 20mm x 8cm stainless steel tubular retractor, Part No. 9569725 RECALL NUMBER # Z-0745-06; PRODUCT bb) METRx II Tube, 20mm x 9cm stainless steel tubular retractor, Part No. 9569726 RECALL NUMBER # Z-0746-06; PRODUCT cc) METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730 RECALL NUMBER # Z-0747-06; PRODUCT dd) METRx II Tube, 22mm x 4cm stainless steel tubular retractor, Part No. 9569731 RECALL NUMBER # Z-0748-06; PRODUCT ee) METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732 RECALL NUMBER # Z-0749-06; PRODUCT ff) METRx II Tube, 22mm x 6cm stainless steel tubular retractor, Part No. 9569733 RECALL NUMBER # Z-0750-06; PRODUCT gg) METRx II Tube, 22mm x 7cm stainless steel tubular retractor, Part No. 9569734 RECALL NUMBER # Z-0751-06; PRODUCT hh) METRx II Tube, 22mm x 8cm stainless steel tubular retractor, Part No. 9569735 RECALL NUMBER # Z-0752-06; PRODUCT ii) METRx II Tube, 22mm x 9cm stainless steel tubular retractor, Part No. 9569736 RECALL NUMBER # Z-0753-06 CODE a) Lot No. FA05K003; b) Lot No. FA05K004; c) Lot No. FA05K005; d) Lot No. FA05K006; e) Lot No. FA05K007; f) Lot No. FA05K008; g) Lot No. FA05K009; h) Lot No. FA05K010; i) Lot No. FA05K011; j) Lot No. FA05K012; k) Lot No. FA05K013; l) Lot No. FA05K014; m) Lot No. FA05K015; n) Lot No. FA05K016; o) Lot No. FA05K017; p) Lot No. FA05K018; q) Lot No. FA05K019; r) Lot No. FA05K020; s) Lot No. FA05K021; t) Lot No. FA05K022; u) Lot No. FA05K023; v) Lot No. DC05L012; w) Lot No. DC05L013; x) Lot No. DC05L014; y) Lot No. DC05L015; z) Lot No. DC05L016; aa) Lot No. DC05L017; bb) Lot No. DC05L018; cc) Lot No. DC05L005; dd) Lot No. DC05L006; ee) Lot No. DC05L007; ff) Lot No. DC05L008; gg) Lot No. DC05L009; hh) Lot No. DC05L010; ii) Lot No. DC05L011 MANUFACTURED & RECALLED BY Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN QUANTITY 61 devices DISTRIBUTION IL, IN, MI, CA, Japan, and Netherlands REASON Due to a manufacturing error, after autoclaving, the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. --------------------------------------------------------------------------- 1