medical Class II Updated 2021-09-08

Aspen Surgical Products, Inc. recalls Marco Shoulder Stabilization Kit, Product Code 711100, (prev

Recalled Product

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots manufactured between July 9, 2019 to July 9, 2021
View official government recall

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