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Encore Medical, LP recalls DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coa
Recalled September 27, 2023 · FDA recall Z-2606-2023 · Encore Medical
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 · FDA Class II
Units
64
Sold at
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
Description
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
Product
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
Manufacturer(s)
Encore Medical, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →