Aspen Surgical Products, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2389-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 23, 2021

Date Posted: September 8, 2021

Recall Number: Z-2389-2021

Event ID: 88476

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4270

Code Information:

All lots manufactured between July 9, 2019 to July 9, 2021

Distribution Pattern:

US nationwide distribution. No foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated