Z-2606-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64
Product Description
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 System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
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 Pattern
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
Code Information
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