Aspen Surgical recalls Marco Shoulder Stabilization Kit (product codes 711100 and 100601) manufactured between July 2019 and July 2021 due to potential unsterilized materials that could cause surgical infections.
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.
Aspen Surgical is recalling Marco Shoulder Stabilization Kits made between July 2019 and July 2021 because they might not have been properly sterilized. This could lead to surgical site infections if used in procedures.
The kits were made with materials that may not have been fully sterilized during production. This could mean the kits might not be sterile enough for surgery, increasing the chance of infection at the surgical site.
Surgical teams and hospitals that used the Marco Shoulder Stabilization Kit with product codes 711100 or 100601 manufactured between July 9, 2019 and July 9, 2021 are most at risk.
Check for product codes 711100 (current) or 100601 (previous) on the kit. The kits were sold between July 9, 2019 and July 9, 2021.
Look for product code 711100 or 100601 on the kit packaging or label.
The kits were manufactured with materials that may not have been fully sterilized, which could increase the risk of surgical site infections.
The official recall notice does not specify a remedy or action for affected kits.
The kits were manufactured between July 9, 2019 and July 9, 2021.
We’ve drafted a message you can send Aspen Surgical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-2389-2021 — Aspen Surgical Products Aspen Surgical Products Hello, I own a Aspen Surgical Products that is covered by recall Z-2389-2021 from Aspen Surgical Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
