Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2390-2021 — Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

U.S. FDA — Device Enforcement · United States · 2021-07-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2390-2021
Date of alert
2021-07-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aspen Surgical Products, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.