Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility
Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile surgical device used in invasive orthopedic procedures that cannot be confirmed as sterile, creating risk of harm. No illnesses or injuries have been reported in the source material, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Synthes (USA) Products LLC is recalling 144 units of the RIA Tube Assembly (Part Number 314.746S, UDI: 10886982189080). This sterile surgical instrument is intended for use in adults and adolescents (12-21 years) to clear bone marrow and debris from the medullary canal, size the medullary canal for implant placement, harvest autogenous bone and bone marrow for bone grafting, and remove infected or necrotic tissue during osteomyelitis treatment.
The recalled devices cannot be confirmed as sterile, which creates a risk of infection if used in invasive surgical procedures. The U.S. Food and Drug Administration has classified this as a Class II recall (FDA Recall Number: Z-1237-2024).
The affected lot numbers are H802995, H803000, H803020, and H830033. The devices were distributed worldwide, including throughout the United States and to Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, and South Africa.
Healthcare facilities that received these devices should quarantine them immediately. The devices should not be used until sterility can be confirmed.
The recalled product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 10886982189080 Lot Number: H802995
- H803000
- H803020
- H830033
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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