Ethicon Endo Surgery, LLC: ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

Hazard

Identified curing issues with the silicone during the needles manufacturing process.

Details from the source

Reason for recall: Identified curing issues with the silicone during the needles manufacturing process. Distribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay. Quantity: 2,556 units Lot/code info: Product Code: X843H-56; GMDN: 13906; UDI-DI: 10705031058088; Lot number: 10489X ;

UPC codes

10705031058088

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.