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
Enforcement
- Recall Number
- Z-1237-2024
- Event ID
- 93924
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 13, 2024
- Initiation Date
- January 24, 2024
- Classification Date
- March 1, 2024
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States
Description
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
Products not sterilized, sterility cannot be confirmed
UDI: 10886982189080 Lot Number: H802995, H803000, H803020, H830033
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.
144 units