FDA recall Z-0575-2021

Product

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

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-11-19

Report date

2020-12-23

Termination date

2022-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2021