Recall Z-2674-2026— Zimmer Surgical Inc
Class II · Ongoing
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2026-06-09. Product: Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A. 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..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-09
- Firm location
- Dover, OH, United States
Product description
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.