DePuy Synthes 15.5mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 15.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, 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 a medical device defect that results in adverse tissue reaction, soft tissue damage, and/or bone damage, meeting the criteria for a Severe rating.
Plain-English summary
Synthes (USA) Products LLC is recalling the DePuy Synthes 15.5mm Reamer Head for RIA 2, a sterile orthopedic manual surgical instrument (Part Code: 03.404.027S). The recall involves 642 units in the United States and 325 units outside the United States. 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.
The recall is being conducted because the reamer head breakage exceeds the expected occurrence rate. This breakage can result in adverse tissue reaction, soft tissue damage, and/or bone damage when the recommended surgical techniques are not followed. The agency has classified this recall as Class II.
Healthcare providers and facilities that have received this product should stop using it immediately and contact the recalling firm for instructions on return or disposal. Patients who have had this device implanted should consult their healthcare provider if they experience any complications.
The recalled product
- Product
- DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
- 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:10886982273994
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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