Agency classClass IIOur severity:High FDA (Devices)·Z-1262-2024·Announced 2024-03-13

Howmedica X3 Triathlon CS Insert Recalled for Packaging Defects

Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert (Part No. 5531-G-709-E, Lot KA1Y71) due to potential inner and outer sterile blister packaging breaches. No injuries have been reported.

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: FDA Class II medical device with a potential sterility compromise from packaging breach, but no injuries or illnesses reported. Per the rubric, a risk-of-harm product (sterility risk in a surgical implant) where injury has not yet been reported scores 3 (High).

Plain-English summary

The X3 Triathlon CS Insert No 7 9 MM, a knee replacement orthopedic component manufactured by Howmedica Osteonics Corp., has been recalled due to potential packaging defects. The affected product has Part Number 5531-G-709-E, GTIN 07613327337464, Lot Number KA1Y71, and an expiration date of November 8, 2028. Twenty-four units were distributed in the United States.

The recall was initiated due to potential breaches in both the inner blister and outer sterile blister packaging. These defects could compromise the sterility of the medical device.

The product was distributed domestically throughout the United States and internationally to Australia, Canada, Chile, Colombia, Korea, and Japan.

Healthcare facilities and providers in possession of the recalled product should discontinue use and contact Howmedica Osteonics Corp. for return or replacement instructions. No injuries or infections have been reported in association with this recall.

The recalled product

Product: X3 TRIATHLON CS INSERT NO 7 9 MM
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic Joint Insert
Hazard: sterility-breach
packaging-defect
Affected units: 24

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 (4)

Part No. 5531-G-709-E
GTIN: 07613327337464
Lot No. KA1Y71
Expiration Date: 11/08/2028.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · sterility breach