FDA Device recall Z-1237-2024
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of…
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of… by Synthes Usa Products, citing products not sterilized, sterility cannot be confirmed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1237-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-24 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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
Identifiers
| code_info | UDI: 10886982189080 Lot Number: H802995, H803000, H803020, H830033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2024-06-05 · Synthes Usa Products
All Synthes Usa Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1237-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.