Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2016 - (Recall #: Z-2377-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 23, 2016

Date Posted: August 17, 2016

Recall Number: Z-2377-2016

Event ID: 74634

Reason for Recall:

Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.

Status: Terminated

Product Quantity: 12,469 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated