NRAC Issue #1660 ADDENDUM December 11, 2007 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT 1) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430 RECALL NUMBER # Z-0385-2008 PRODUCT 2) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431 RECALL NUMBER # Z-0386-2008 PRODUCT 3) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432 RECALL NUMBER # Z-0387-2008 PRODUCT 4) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433 RECALL NUMBER # Z-0388-2008 PRODUCT 5) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440 RECALL NUMBER # Z-0389-2008 PRODUCT 6) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441 RECALL NUMBER # Z-0390-2008 PRODUCT 7) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442 RECALL NUMBER # Z-0391-2008 PRODUCT 8) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451 RECALL NUMBER # Z-0392-2008 PRODUCT 9) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452 RECALL NUMBER # Z-0393-2008 PRODUCT 10) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453 RECALL NUMBER # Z-0394-2008 PRODUCT 11) Depuy P.F.C. (r) E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471 RECALL NUMBER # Z-0395-2008 PRODUCT 12) Depuy P.F.C. (r) E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521 RECALL NUMBER # Z-0396-2008 PRODUCT 13) Depuy P.F.C. (r) E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522 RECALL NUMBER # Z-0397-2008 PRODUCT 14) Depuy P.F.C. (r) E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523 RECALL NUMBER # Z-0398-2008 PRODUCT 15) Depuy P.F.C. (r) E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527 RECALL NUMBER # Z-0399-2008 PRODUCT 16) Depuy P.F.C. (r) E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544 RECALL NUMBER # Z-0400-2008 PRODUCT 17) Depuy P.F.C. (r) E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551 RECALL NUMBER # Z-0401-2008 PRODUCT 18) Depuy P.F.C. (r) E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630 RECALL NUMBER # Z-0402-2008 PRODUCT 19) Depuy P.F.C. (r) E Knee System All Polyethylene Curved Tibial Component, 3, 8mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640 RECALL NUMBER # Z-0403-2008 PRODUCT 20) Depuy P.F.C. (r) E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641 RECALL NUMBER # Z-0404-2008 PRODUCT 21) Depuy P.F.C. (r) E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650 RECALL NUMBER # Z-0405-2008 PRODUCT 22) Depuy P.F.C. (r) E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651 RECALL NUMBER # Z-0406-2008 PRODUCT 23) Depuy P.F.C. (r) E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663 RECALL NUMBER # Z-0407-2008 PRODUCT 24) Depuy P.F.C. (r) E RP Knee System Rotating Platform Curved Tibial Insert (RP-CVD), 10mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2041 RECALL NUMBER # Z-0408-2008 PRODUCT 25) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5mm, Size 2.5, UHMWPE, sterile; Product Code/REF 96-2122 RECALL NUMBER # Z-0409-2008 PRODUCT 26) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2131 RECALL NUMBER # Z-0410-2008 PRODUCT 27) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132 RECALL NUMBER # Z-0411-2008 PRODUCT 28) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 15 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2133 RECALL NUMBER # Z-0412-2008 PRODUCT 29) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2134 RECALL NUMBER # Z-0413-2008 PRODUCT 30) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2141 RECALL NUMBER # Z-0414-2008 PRODUCT 31) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2142 RECALL NUMBER # Z-0415-2008 PRODUCT 32) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2161 RECALL NUMBER # Z-0416-2008 PRODUCT 33) Depuy P.F.C. (r) E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2164 RECALL NUMBER # Z-0417-2008 PRODUCT 34) Depuy P.F.C. (r) E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643 RECALL NUMBER # Z-0418-2008 PRODUCT 35) Depuy P.F.C. (r) E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650 RECALL NUMBER # Z-0419-2008 PRODUCT 36) Depuy P.F.C. (r) E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652 RECALL NUMBER # Z-0420-2008 PRODUCT 37) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712 RECALL NUMBER # Z-0421-2008 PRODUCT 38) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713 RECALL NUMBER # Z-0422-2008 PRODUCT 39) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF 96-2730 RECALL NUMBER # Z-0423-2008 PRODUCT 40) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2731 RECALL NUMBER # Z-0424-2008 PRODUCT 41) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF 96-2732 RECALL NUMBER # Z-0425-2008 PRODUCT 42) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2733 RECALL NUMBER # Z-0426-2008 PRODUCT 43) Depuy P.F.C. (r) E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF 96-2736 RECALL NUMBER # Z-0427-2008 PRODUCT 44) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310 RECALL NUMBER # Z-0428-2008 PRODUCT 45) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410 RECALL NUMBER # Z-0429-2008 PRODUCT 46) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206 RECALL NUMBER # Z-0430-2008 PRODUCT 47) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208 RECALL NUMBER # Z-0431-2008 PRODUCT 48) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406 RECALL NUMBER # Z-0432-2008 PRODUCT 49) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506 RECALL NUMBER # Z-0433-2008 CODE 1) Lot 79691A 2) Lots 77219A, 77311A, 80904A, 81029A and 81189A 3) Lots 77217A, 77218A, 79709A and 81043A 4) Lots 77216A and 81807A 5) Lots 81357A and 81354A 6) Lots 80303A, 80304A, 80318A, 80319A, 80320A, 81323A, 81336A, 81342A, 81343A, 81344A, 81346A, 81460A and 81470A 7) Lots 78272A, 81303A and 81321A 8) Lots 80370A and 80373A 9) Lot 80347A 10) Lots 80340A and 80341A 11) Lot 81226A 12) Lot 78904A 13) Lot 79277A 14) Lot 79273A 15) Lot 79272A 16) Lot 80278A 17) Lot 79657A 18) Lot 79927A 19) Lots 77471A, 81083A and 81271A 20) Lot 81160A 21) Lot 81248A 22) Lot 81254A 23) Lot 80981A 24) Lots 81170A and 81197A 25) Lot 77454A 26) Lots 79530A, 79646A, 79873A, 79874A, 79932A, 80690A, 80714A, 80931A and 80940A 27) Lots 79635A, 79856A, 79861A, 79865A, 80656A, 80661A and 80655A 28) Lots 80745A, 80746A and 80763A 29) Lot 80737A 30) Lots 79597A, 79795A, 80832A and 80874A 31) Lots 80911A and 80818A 32) Lot 77436A 33) Lot 77465A 34) Lot 81084A 35) Lot 81257A 36) Lot 81268A 37) Lot 79067A 38) Lot 79066A 39) Lot 79065A 40) Lot 79064A 41) Lot 79063A 42) Lot 79062A 43) Lot 80141A 44) Lots XK6D84, XK6D94, XK6EA4, XK6EB4 and XK6EC4 45) Lot W75BT4 46) Lot W77B74 47) Lot XB7C14 48) Lot XJ1CV4 49) Lots W85DF4, W85DG4, W85DJ4, W85DL4 and W85DM4 MANUFACTURED & RECALLED BY Depuy Orthopedics, Inc., Warsaw, IN QUANTITY 1,158 units DISTRIBUTION Nationwide REASON An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. --------------------------------------------------------------------------- 1