DePuy Synthes 17.0mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 17.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves significant injury reports, specifically adverse tissue reaction, soft tissue damage, and bone damage, which aligns with the 'Severe' criteria in the rubric.
Plain-English summary
Synthes (USA) Products LLC is recalling the DePuy Synthes 17.0mm Reamer Head for RIA 2, a sterile orthopedic manual surgical instrument. The recall affects 572 units in the United States and 200 units in foreign countries. The specific part code is 03.404.030S, and the recall covers all lots with UDI 10886982274052.
The recall was initiated because the reamer head breakage rate exceeds the expected occurrence. This breakage can result in adverse tissue reactions, soft tissue damage, and/or bone damage when recommended surgical techniques are not followed. The product was distributed nationwide and to several foreign countries, including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore.
Healthcare providers and facilities should stop using the affected reamer heads and contact Synthes (USA) Products LLC for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device, but patients who have had this device used in surgery should consult their healthcare provider if they experience complications.
The recalled product
- Product
- DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
- Manufacturer
- Synthes (USA) Products LLC
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 (1)
- All Lots UDI: 10886982274052
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 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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