Synthes (USA) Products LLC: Medical Device Recall in 2024 - (Recall #: Z-1237-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 24, 2024

Date Posted: March 13, 2024

Recall Number: Z-1237-2024

Event ID: 93924

Reason for Recall:

Products not sterilized, sterility cannot be confirmed

Status: Ongoing

Product Quantity: 144 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated