Agency classClass IIOur severity:High FDA (Devices)·Z-2377-2016·Announced 2016-08-17

Stryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues

Stryker Howmedica Osteonics is voluntarily recalling Triathlon Modular Handle instruments because press fit specifications were not met, potentially causing disassociation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that could lead to disassociation during surgery, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Stryker Howmedica Osteonics Corp. is voluntarily recalling the Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile. The recall involves 12,469 units distributed worldwide and across the United States. These reusable instruments are part of the Triathlon Primary total knee arthroplasty (TKA) system and the Triathlon Partial Knee Replacement (PKR) system.

The recall was initiated because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved. This defect potentially results in disassociation from the instrument. The handles are used to assist in stabilizing the Triathlon Femoral Sizer, aid in stabilization during the use and removal of the Triathlon 4:1 Cutting Block, and aid in assembly of the Anterior MIS Distal Resection Guide. In PKR surgeries, the handle is required to assemble and disassemble the Femoral Trial Drill Guide and remove the Peg Trial from the Femoral Trial.

Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Howmedica Osteonics for further instructions.

The recalled product

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…
Manufacturer: Stryker Howmedica Osteonics Corp.
Category: Medical Device — Surgical Instruments
Hazard: structural-defect
disassociation
Affected units: 12,469

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Stryker Howmedica Osteonics Corp.

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Same hazard · structural defect