DePuy Synthes 13.0mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 13.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or 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 reported adverse tissue reactions, soft tissue damage, and bone damage, meeting the criteria for a Severe rating.
Plain-English summary
Synthes (USA) Products LLC is recalling DePuy Synthes 13.0mm Reamer Heads for RIA 2 (Part Code: 03.404.022S). The recall involves 1,447 units in the United States and 554 units outside the US. The product is an orthopedic manual surgical instrument.
The recall is being conducted 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 agency has classified this as a Class II recall.
The affected units were distributed nationwide and in foreign countries including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore. All lots are affected, identified by UDI 10886982274021. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
- 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: 10886982274021
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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