Synthes (USA) Products LLC: Medical Device Recall in 2020 - (Recall #: Z-0576-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 19, 2020

Date Posted: December 23, 2020

Recall Number: Z-0576-2021

Event ID: 86713

Reason for Recall:

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

Status: Terminated

Product Quantity: 1337 US; 453 OUS

Code Information:

All Lots UDI: 10886982274007

Distribution Pattern:

Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,

Voluntary or Mandated:

Voluntary: Firm initiated