The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2757-2019·Announced 2019-10-09

Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

Howmedica Osteonics Corp. is recalling 167 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

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 agency classified this as an FDA Class II recall. The hazard involves a structural defect (device overhang) in a medical implant, which presents a risk of harm, but the source text does not report specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling 167 units of the Triathlon Femoral Distal Augment 10mm - Size 2 Left (Catalog # 5541-A-201). These medical devices are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects.

The recall is being conducted due to a device overhang issue where the augment protrudes beyond the medial periphery of the mating femoral component. The affected units are all lots with an expiration date on or before June 31, 2024. The specific lot numbers are listed in the source metadata.

The products were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. Healthcare providers and patients should contact Howmedica Osteonics Corp. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to…
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
167

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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