FDAFDA · Food and drugs·Recall number Z-1237-2024
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S
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: 10886982189080 Lot Number: H802995, H803000, H803020, H830033
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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