Device Recall Stryker

Catalog No. 6541-4-808 Lot Nos.: SB1K14, SB1K14A, SB1K14A1, SB1K14P, SB1K15, SB1K15A, SB1K15A1, SB1K15A2, SB1M25, SB1M25A, SB1M25A1, SB1M25A2, SB1M25A2X1, SB1N02, SB1N02A, SB1N02A1, SB1N02A2, SB1N02A3, SB1N02X1, SB1T05, SB1T05A, SB1T05A1, SB1T05AX1, SB1T05AX2, SB1T05KSB1V01, SB1V01K, SB1V01L, SB1V01X1, SB1V01X2, SB1V01X3, SB1W14, SB1W14K, SB1W14X1, SB2T19, SB2T19A, SB2T19D, SB2T19DX1, SB2T19DX2, SB2T19J, SB2T19K, SB2T19KX1, SB2T19KX2, SBT19X3, SB2V87, SB2V87A, SB2V87J, SB2V87JX1, SB2V87K, SB2V87X, SB2V87X1, SB2W23, SB2W23G, SB2W23X, SB2W23X1, SB3A20, SB3A20A, SB3A21, SB3A21D, SB3A21M, SB3A21X, SB3A22, SB3A22A1, SB3A22X1, SB3A55, SB3A55A, SB3A55A2, SB3A55AX1, SB3A55M, SB3A55X1, SB3H25, SB3H25D, SB3H25G, SB3H25X1, SB3H26, SB3H26D, SB3H26DX1, SB3H26X2, SB3K09, SB3K09X1, SB3K10, SB3K10L, SB3K10M, SB3K10MX1, SB3K10X1, SB3L19, SB3L19D, SB3L19K, SB3L19L, SB3L19P, SB3L19P1, SB3L20, SB3L20K, SB3L45, SB3L45A, SB3L45A1, SB3L45A2, SB3L45D, SB3L45DX1, SB3L45L, SB3L45T, SB3M17, SB3M17A, SB3M17K, SB3M17M, SB3M18, SB3M18A, SB3M18AX1, SB3M18D, SB3M18M, SB3M18R, SB3M19, SB3M19A, SB3M19A1, SB3M19S, SB3M19T, SB3M19W, SB3N46, SB3N46D, SB3N46P, SB3N46X1, SB4C12, SB4C12X1, SB4C37, SB4C37X1, SB4C38, SB4C38A, SB4C38D, SB4E18, SB4E181, SB4E181X1, SB4E18A, SB4E18D, SB4E18T, SB4H79, SB4H79A, SB4H79M, SB4L05, SB4L05A, SB4N17, SB4N17E, SB4N17M, SB4N17M1, SB4N18, SB4N18A, SB4N18A1, SB4N18D, SB4N18M, SB4N18T, SB4S01, SB4S01D, SB4S01J, SB4V07, SB4V07L, SB4V07M, SB4V07MM, SB5A02, SB5A02A, SB5A02A1, SB5A55

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide

Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S || Product Usage: || Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.