Z-1237-2024 Class II Ongoing
FDA device recall Z-1237-2024 was initiated by Synthes (USA) Products LLC on January 24, 2024 and is designated Class II. Reason for recall: Products not sterilized, sterility cannot be confirmed The recall status is ongoing. Affected quantity: 144 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2024
- Initiation Date
- January 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 units
Product 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
Reason for Recall
Products not sterilized, sterility cannot be confirmed
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.
Code Information
UDI: 10886982189080 Lot Number: H802995, H803000, H803020, H830033