Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
US nationwide distribution. No foreign distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2389-2021