Synthes (USA) Products LLC: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

Agency Publication Date: December 15, 2020

Affected Products

Product: DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S

All Lots UDI: 10886982274021

Product: DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S

All Lots UDI: 10886982274045

Product: DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S

All Lots UDI: 10886982274069

Product: DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S

All Lots UDI: 10886982274083

Product: DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S

All Lots UDI: 10886982273956

Product: DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S

All Lots UDI:10886982273994

Product: DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S

All Lots UDI: 10886982274014

Product: DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S

All Lots UDI: 10886982274038

Product: DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S

All Lots UDI: 10886982274052

Product: DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S

All Lots UDI: 10886982274076

Product: DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S

All Lots UDI: 10886982274090

Product: DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S

All Lots UDI: 10886982274007

Product: DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S

All Lots UDI: 10886982273970

Product: DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S

All Lots UDI: 10886982273987

Product: DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S

All Lots UDI: 10886982273932

Product: DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S

All Lots UDI: 10886982273949

Product: DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S

All Lots UDI: 10886982273963

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86713

Status: Resolved

Manufacturer: Synthes (USA) Products LLC

Manufactured In: United States

Units Affected: 17 products (1297 US 528 OUS; 1066 US; 397 OUS; 1275 US and 445 OUS; 1231US; 422 OUS; 1566 US ; 732 OUS; 1337 US; 453 OUS; 1447 US; 554 OUS; 1262 US; 549 OUS; 1328 US ; 578 OUS; 1142 US; 450 OUS; 748 US; 381 OUS; 642 US; 325 OUS; 651US : 326 OUS; 531 US; 317 OUS; 572 US; 200 OUS; 515 US; 150 OUS; 542 US ; 154 OUS)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.