DePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 10.5mm 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 recall is classified as FDA Class II and involves a medical device defect that results in soft tissue and bone damage, meeting the criteria for a Severe rating.
Plain-English summary
Synthes (USA) Products LLC is recalling the DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE, an orthopedic manual surgical instrument. The recall involves 1,066 units in the United States and 397 units outside the United States. The product is identified by Part Code 03.404.017S and UDI 10886982273949. Distribution was nationwide and in 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.
Healthcare providers and facilities that have received this product should stop using it and contact the recalling firm for instructions on return or replacement. Patients who have had this device implanted should contact their healthcare provider if they experience any complications.
The recalled product
- Product
- DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
- 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: 10886982273949
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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