DePuy Synthes 13.5mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 13.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly reports adverse tissue reactions, soft tissue damage, and bone damage, which aligns with the rubric criterion for 'significant injury reports' under a Severe (Score 4) classification.
Plain-English summary
Synthes (USA) Products LLC is recalling DePuy Synthes 13.5mm Reamer Heads for RIA 2 (Part Code: 03.404.023S). The recall involves 1,262 units in the United States and 549 units in foreign countries. The affected products are sterile orthopedic manual surgical instruments.
The recall is being issued because the reamer head breakage rate exceeds the expected occurrence. When the recommended surgical techniques are not followed, this breakage can result in adverse tissue reactions, soft tissue damage, and/or bone damage.
The affected units were distributed nationwide in the United States 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. Healthcare providers should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
- 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: 10886982274045
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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