FDAFDA · Food and drugs·Recall number Z-1261-2024
X3 TRIATHLON CS INSERT NO 6 11 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-611-E; GTIN: 07613327337341; Lot No. HL7228; Expiration Date: 11/08/2028.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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