Device product
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
Z-1237-2024
Product summary
- Event
- Event 93924
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 144 units
- Official record key
device-enforcement:Z-1237-2024
Official wording
Reason: Products not sterilized, sterility cannot be confirmed
Code information: UDI: 10886982189080 Lot Number: H802995, H803000, H803020, H830033
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
sterility cannot be confirmed