DePuy Synthes 16.5mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 16.5mm reamer heads because breakage exceeds expected rates, causing 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 significant injury reports, specifically soft tissue damage and bone damage, which aligns with the Severe criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling DePuy Synthes 16.5mm reamer heads for RIA 2 sterile orthopedic manual surgical instruments. The recall affects 531 units in the United States and 317 units outside the United States. The product is identified by Part Code 03.404.029S and UDI 10886982274038.
The recall was initiated because reamer head breakage exceeds the expected occurrence rate. This breakage can result in adverse tissue reaction, soft tissue damage, and/or bone damage when recommended surgical techniques are not followed.
The product was 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. Healthcare providers should stop using the affected devices and contact the recalling firm for instructions.
The recalled product
- Product
- DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
- 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: 10886982274038
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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