FDAFDA · Food and drugs·Recall number Z-1234-2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Published March 13, 2024 · Recall initiated: January 24, 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
Products not sterilized, sterility cannot be confirmed
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
- Lot
- UDI: 10886982087331 Lot Number: 41P2222
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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