Stryker Howmedica Osteonics Corp.: 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.

Recall number

Z-2377-2016

Recalling firm

Stryker Howmedica Osteonics Corp.

Product

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.

Status

Terminated

Initiated

2016-06-23

Posted

not on file

Terminated

2019-03-27

Reason

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.

Root cause

Device Design

Action

Stryker sent an Urgent Product Recall letter dated June 24, 2016 to Branches/Agencies by e-mail and Business Reply Forms was sent to Branches/Agents/Hospital Risk Management via UPS (with return receipt) on June 24, 2016. The letter identified the affected product, problem and actions to be taken. For questions call (201) 831-6693.

Quantity

12,469 units

Distribution

Worldwide Distribution - US Nationwide

Lot, serial or model codes

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

510(k) numbers

["K143393"]

PMA numbers

not on file

Product code

JWH

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy