DePuy Synthes 12.0mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 12.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or 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 recall is classified as FDA Class II and involves a risk of significant injury, specifically soft tissue and bone damage, which aligns with the 'Severe' criteria for Class II recalls with injury reports.
Plain-English summary
Synthes (USA) Products LLC is recalling DePuy Synthes 12.0mm Reamer Heads for RIA 2, sterile orthopedic manual surgical instruments. The recall covers 1,566 units distributed in the United States and 732 units distributed in foreign countries, including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore. The product is identified by Part Code 03.404.020S and UDI 10886982273987.
The recall is being conducted because the reamer head breakage rate exceeds the expected occurrence. This breakage can result in adverse tissue reaction, soft tissue damage, and/or bone damage when recommended surgical techniques are not followed.
Healthcare providers and facilities that have received these instruments should stop using them and contact Synthes (USA) Products LLC for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
- 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: 10886982273987
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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