FDA-Device2021-09-08Class II
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Aspen Surgical Products, Inc.
Hazard
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.
Sold states
US nationwide distribution. No foreign distribution.
Affected count
4270
Manufactured in
6945 Southbelt Dr SE, N/A, Caledonia, MI, United States
Products
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2389-2021Don't want to check this manually?
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