Class II — Zimmer Surgical Inc
| Recalling firm | Zimmer Surgical Inc |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. |
| Product | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S® 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A |
| Quantity | 45160 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and EMEA. |
| Initiated | 2026-06-09 |
| Classified | 2026-07-02 |
| Recall number | Z-2673-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zimmer Surgical Inc (Z-2673-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99186/
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