Encore Medical, LP: DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder Syst

Hazard

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

Details from the source

Reason for recall: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery Distribution: US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany Quantity: 64 Lot/code info: REF/UDI-DI/Lot/Expiration: 508-01-032/00888912024693/859C1190/April 29, 2027; 508-32-104/00888912024754/866C3153/May 25, 2029 and 866C3147/April 3, 2029; 508-36-101/869C3539/April 30, 2028

UPC codes

00888912024693, 00888912024754

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.