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FDAFDA · Food and drugs·Recall number Z-1260-2024

X3 TRIATHLON CS INSERT NO 6 10 MM

Published March 13, 2024 · Recall initiated: February 6, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential packaging breaches of inner blister and outer sterile blister.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Howmedica Osteonics Corp.
Distributor
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Lot
Part No. 5531-G-610-E; GTIN: 07613327390575; Lot No. 1L0WAY, 323EAY, A72D9D, 9885E1, 9Y397R, L573YP; Expiration Date: 10/07/2028.
Risk classification
Class II
Area (FDA)
device
Country
United States

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