DeviceClearance

Recall Z-1237-2024— Synthes (USA) Products LLC

Class II · Ongoing

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2024-01-24. It names 3 FDA 510(k) clearances: K111437, K042899, K013527. 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. Reason: Products not sterilized, sterility cannot be confirmed.

Recalling firm
Synthes (USA) Products LLC
Classification
Class II
Status
Ongoing
Initiated
2024-01-24
Firm location
West Chester, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.