← FDA ENFORCEMENT
Z-2673-2026Class II

Zimmer Surgical Inc

Recalling firm
Zimmer Surgical Inc
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
Firm state
OH
Product quantity
45160
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Product description

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

Code / lot info

Lot Code: Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271 ; Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271 ; Individual UDI (01)00889024367173(17)271125(10)78938271 ; Lot Number 78938271 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272 ; Box (10-Pack) UDI (01)00889024378469(17)271126(10)78938272 ; Individual UDI (01)00889024367173(17)271126(10)78938272 ; Lot Number 78938272 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271127(10)78938273 ; Box (10-Pack) UDI (01)00889024378469(17)271127(10)78938273 ; Individual UDI (01)00889024367173(17)271127(10)78938273 ; Lot Number 78938273 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280206(10)80555986 ; Box (10-Pack) UDI (01)00889024378469(17)280206(10)80555986 ; Individual UDI (01)00889024367173(17)280206(10)80555986 ; Lot Number 80555986 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280102(10)80555987 ; Box (10-Pack) UDI (01)00889024378469(17)280102(10)80555987 ; Individual UDI (01)00889024367173(17)280102(10)80555987 ; Lot Number 80555987 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280210(10)80555988 ; Box (10-Pack) UDI (01)00889024378469(17)280210(10)80555988 ; Individual UDI (01)00889024367173(17)280210(10)80555988 ; Lot Number 80555988 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280214(10)80555989 ; Box (10-Pack) UDI (01)00889024378469(17)280214(10)80555989 ; Individual UDI (01)00889024367173(17)280214(10)80555989 ; Lot Number 80555989 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280217(10)80555990 ; Box (10-Pack) UDI (01)00889024378469(17)280217(10)80555990 ; Individual UDI (01)00889024367173(17)280217(10)80555990 ; Lot Number 80555990 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280225(10)80568849 ; Box (10-Pack) UDI (01)00889024378469(17)280225(10)80568849 ; Individual UDI (01)00889024367173(17)280225(10)80568849 ; Lot Number 80568849 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280409(10)82010858 ; Box (10-Pack) UDI (01)00889024378469(17)280409(10)82010858 ; Individual UDI (01)00889024367173(17)280409(10)82010858 ; Lot Number 82010858 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280403(10)82010859 ; Box (10-Pack) UDI (01)00889024378469(17)280403(10)82010859 ; Individual UDI (01)00889024367173(17)280403(10)82010859 ; Lot Number 82010859 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280415(10)82196691 ; Box (10-Pack) UDI (01)00889024378469(17)280415(10)82196691 ; Individual UDI (01)00889024367173(17)280415(10)82196691 ; Lot Number 82196691 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280419(10)82196692 ; Box (10-Pack) UDI (01)00889024378469(17)280419(10)82196692 ; Individual UDI (01)00889024367173(17)280419(10)82196692 ; Lot Number 82196692 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280423(10)82331021 ; Box (10-Pack) UDI (01)00889024378469(17)280423(10)82331021 ; Individual UDI (01)00889024367173(17)280423(10)82331021 ; Lot Number 82331021 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280427(10)82331022 ; Box (10-Pack) UDI (01)00889024378469(17)280427(10)82331022 ; Individual UDI (01)00889024367173(17)280427(10)82331022 ; Lot Number 82331022 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280501(10)82418900 ; Box (10-Pack) UDI (01)00889024378469(17)280501(10)82418900 ; Individual UDI (01)00889024367173(17)280501(10)82418900 ; Lot Number 82418900 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280507(10)82418901 ; Box (10-Pack) UDI (01)00889024378469(17)280507(10)82418901 ; Individual UDI (01)00889024367173(17)280507(10)82418901 ; Lot Number 82418901 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280513(10)82639501 ; Box (10-Pack) UDI (01)00889024378469(17)280513(10)82639501 ; Individual UDI (01)00889024367173(17)280513(10)82639501 ; Lot Number 82639501 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280516(10)82761025 ; Box (10-Pack) UDI (01)00889024378469(17)280516(10)82761025 ; Individual UDI (01)00889024367173(17)280516(10)82761025 ; Lot Number 82761025 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280529(10)83343102 ; Box (10-Pack) UDI (01)00889024378469(17)280529(10)83343102 ; Individual UDI (01)00889024367173(17)280529(10)83343102 ; Lot Number 83343102 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280820(10)84859541 ; Box (10-Pack) UDI (01)00889024378469(17)280820(10)84859541 ; Individual UDI (01)00889024367173(17)280820(10)84859541 ; Lot Number 84859541 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280902(10)84859542 ; Box (10-Pack) UDI (01)00889024378469(17)280902(10)84859542 ; Individual UDI (01)00889024367173(17)280902(10)84859542 ; Lot Number 84859542 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)281112(10)86156905 ; Box (10-Pack) UDI (01)00889024378469(17)281112(10)86156905 ; Individual UDI (01)00889024367173(17)281112(10)86156905 ; Lot Number 86156905

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.